System, Thermal Regulating
FDA product code DWJ · 157 cleared devices
Class 2
Cardiovascular
- Regulation
- 21 CFR 870.5900
- Review panel
- CV
- Implant
- No
- Life sustaining
- No
- Third party review
- Yes
- GMP exempt
- No
- Clearance span
- 1976-12-06 – 2026-08-21
If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
DWJ
2000-03-28
DWJ
2000-03-07
ALLON 2000
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DWJ
2000-03-01
CHILLBUSTER PORTABLE ELECTRIC BLANKET SYSTEM, MODEL 8001
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DWJ
1998-08-07
CONTOR TABLE SURFACE
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DWJ
1997-12-17
THERMO-STAT SYSTEM
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DWJ
1997-06-26
BAIR HUGGER MODEL 630 CARDIAC BLANKET
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DWJ
1997-04-23
THERMAL REGULATION SYSTEM BLANKET
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DWJ
1997-04-22
TRU-5000 THERMAL RECOVERY RADIANT HEATING UNIT
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DWJ
1997-01-13
GIBECK WARMBAG REUSABLE CONVECTIVE WARMING BLANKET
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DWJ
1996-06-17
SYSTEM, THERMAL REGULATING 74-DWJ
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DWJ
1996-01-17
LIFE-AIR 1000 HYPOTHERMIC THERAPY SYSTEM
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DWJ
1995-09-12
BAIR HUGGER MODEL 655 BLANKET
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DWJ
1995-09-06
TROPICAIR CONVECTIVE WARMING BLANKETS
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DWJ
1995-09-06
TROPICAIR CONVECTIVE WARING SYSTEM
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DWJ
1995-08-29
BAIR HUGGER MODEL 600 UNIT, BLANKETS
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DWJ
1995-05-23
TC 3000
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DWJ
1995-01-24
WARM AIR HYPERTHEERMIA SYSTEM (MODELS #130 AND #133)
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DWJ
1995-01-24
WARM AIR WARMING UNIT
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DWJ
1994-09-19
WARMTOUCH PLASTIC WARMING COVER
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DWJ
1994-03-09
CABOT MEDICAL NIAGRA-TRS THERMAL RETENTION SYSTEM
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DWJ
1993-11-09
LIFE-AIR 1000 PATIENT WARMING COVER
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DWJ
1993-08-06
TC2000 POWER UNIT AND ACCESSORIES
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DWJ
1993-07-13
TROPIC-AIR
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DWJ
1992-12-11
SOFT-TEMP
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DWJ
1992-08-06
BAIR HUGGER TORSO BLANKET - ARMS IN MODEL 540
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DWJ
1992-06-18
BAIR HUGGER CUB BLANKET- SHORT MODEL 536
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DWJ
1992-04-21
LIFE-AIR 1000 HYPOTHERMIC TREATMENT SYSTEM
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DWJ
1992-03-30
LIFE-AIR 1000 PATIENT WARMING COVERS
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DWJ
1992-03-27
BAIR HUGGER PATIENT WARMING SYSTEM
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DWJ
1992-01-07
TC-1000, TC-1050 SYSTEM
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DWJ
1991-10-23
BAIR HUGGER(R) PATIENT WARM SYST/BABY WARM COVER
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DWJ
1991-09-04
WARMTOUCH
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DWJ
1991-07-30
MEDI-THERM (MTA-5900) & DETACHABLE HOSES
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DWJ
1991-05-16
WARMAIR SYSTEM
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DWJ
1991-02-01
TEMP MARQ(TM) CONVECTIVE WARMING SYSTEM
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DWJ
1990-12-20
BODYHEAT
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DWJ
1990-10-22
TROPI-COOL
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DWJ
1990-08-14
BAIR HUGGER(R) PATIENT WARMING SYSTEM-MODIFICATION
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DWJ
1990-04-10
BONCHEK-SHILEY CARDIAC JACKET W/RECIRCULATION SET
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DWJ
1989-11-02
BIO-CAL 370 HEATER/COOLER
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DWJ
1989-05-05
ACCUTHERM PTS-200
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DWJ
1988-09-06
RK2000 K-THERMIA SYSTEM
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DWJ
1988-07-28
HEART-CHILL SALINE SLUSH PAD
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DWJ
1988-06-22
MINI-TEMP(TM)
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DWJ
1988-01-29
VES-TEMP MODEL VT1 MONOPLACE COOL/HEAT SYSTEM
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DWJ
1987-11-06
BAIR HUGGER(TM) - PATIENT WARMING SYSTEM
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DWJ
1986-06-02
THERMORITE MODEL HC-83 HYPO/HYPERTHERMIA UNIT
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DWJ
1982-04-29
THERMO-K
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DWJ
1981-12-29
EAST WATER UNIT MARK 3
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DWJ
1981-08-13
HEMOTHERM MODEL 400
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DWJ
1981-07-16
MAXITHERM
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DWJ
1981-01-02
CREST ELECTRONIC WARMING BLANKET
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DWJ
1980-04-24
MEDI-THERM
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DWJ
1977-11-15
PATIENT HEATER SYSTEM, MODEL PH112
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DWJ
1977-09-06
AQUAMATIC K-MODULE MODEL K-20
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DWJ
1977-06-08
AQUAMATIC K-77
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DWJ
1976-12-06
ELECTRONIC CONTROL UNIT
View details →No matching devices.
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