Spirometer, Monitoring (W/Wo Alarm)
FDA product code BZK · 62 cleared devices
Class 2
Anesthesiology
- Regulation
- 21 CFR 868.1850
- Review panel
- AN
- Implant
- No
- Life sustaining
- No
- Third party review
- Yes
- GMP exempt
- No
- Clearance span
- 1976-12-09 – 2026-09-16
BZK
2026-09-16
BZK
2019-12-18
BEACON Caresystem Model 00002144
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BZK
2019-12-17
ExSpiron 2Xi
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BZK
2018-10-24
Gas Module 3
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BZK
2018-03-16
ExSpiron 1Xi
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BZK
2017-05-09
ExSpiron 1Xi
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BZK
2013-05-29
EXSPIRON 1XI
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BZK
2012-09-26
EXSPIRON
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BZK
2011-06-02
PHILIPS NM3 RESPIRATORY MONITOR WITH VENTASSIST
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BZK
2009-09-21
WRIGHT RESPIROMETER, MARK 8, AND 14 RESPIROMETER, MODEL 700-021, 700-008, 700-014
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BZK
2009-08-21
MERCURY VCO2
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BZK
2009-07-28
PHILIPS NM3 MONITOR, MODEL 7900
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BZK
2008-06-20
MERCURY VCO2 MODULE WITH CAPNOSTAT 5
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BZK
2006-11-02
GAS MODULE SE, MODEL 0998-00-0481-02
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BZK
2005-09-07
CALDYNE, INC. EXHALOMETER EX100, MODEL EX100
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BZK
1998-12-09
STARTRACK INFANT GRAPHICS MONITOR
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BZK
1997-08-12
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS311
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BZK
1993-11-29
CAPNOMAC ULTIMA ANESTHESIA MONITOR
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BZK
1993-10-25
NEWPORT COMPASS EXHALED TIDAL VOLUME MONITOR
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BZK
1992-11-06
BICORE SMARTVALVE OCCLUSION VALVE
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BZK
1991-01-04
MODEL 295 ELECTRONIC RESPIROMETER
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BZK
1990-11-23
NEONATAL METASCOPE
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BZK
1990-09-27
PARTNER VOLUME MONITOR
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BZK
1989-06-12
CAV 3.0C SOFTWARE PROGRAM
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BZK
1989-06-12
MODEL 1010, CY-MET
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BZK
1989-06-08
RESPITRAK
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BZK
1989-06-07
MONAGHAN RVM, MODEL 761
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BZK
1989-03-30
MOFIFICATION BEAR NVM-1 NEONATAL VOLUME MONITOR
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BZK
1988-02-12
BEAR NVM-1
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BZK
1987-03-06
RESPIGRAPH-RESPISOMNOGRAPH-RESPICENTRAL
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BZK
1987-01-28
RESPIRADYNE II(TM)
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BZK
1986-09-24
RESPICENTRAL(TM)
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BZK
1986-09-12
OHMEDA 5420 VOLUME MONITOR
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BZK
1986-09-12
OHMEDA 5410 VOLUME MONITOR
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BZK
1986-03-20
RESPIGRAPH
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BZK
1985-09-11
BEAR NICU-1
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BZK
1985-07-15
RESPITRACE 300SC
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BZK
1984-10-04
OHMEDA RM121 RESPIROMETER
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BZK
1984-10-04
OHMEDA RM311 RESPIROMETER
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BZK
1984-03-30
RICO RESPIRATION MONITOR
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BZK
1984-03-02
MEDISHIELD PVM RESPIROMETER
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BZK
1984-01-20
RESPITRACE 300SC
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BZK
1984-01-11
RESPICOMB
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BZK
1983-09-01
OHIO 5400 VOLUME MONITOR
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BZK
1983-07-12
PORTABLE MONITORING & SCREENING SPIROM.
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BZK
1983-05-09
SPIROMED RESPIROMETER
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BZK
1983-04-28
POCKET SPIROMETER
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BZK
1983-03-07
RESPITRACE SYSTEM
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BZK
1983-02-24
COMPUTERIZED SPIROMETRY SYSTEM
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BZK
1983-01-05
MAGTARAK RESPIRATORY MONITOR & FLOW SENS
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BZK
1982-11-16
BEAR VM-90 VENTILATION MONITOR
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BZK
1982-01-22
SPIROX A
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BZK
1982-01-22
SPIROX H
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BZK
1981-08-07
TIDAL VOLUME MONITOR 150
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BZK
1980-05-08
RMS 111F RESPIRATORY MONITORING SYSTEM
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BZK
1979-12-31
ALARM USED W/MONITORING SPIROMETER
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BZK
1979-12-19
EMPIRE SPIROMETER
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BZK
1979-01-31
SPIROMETER, MINI POSITIVE
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BZK
1978-01-31
SPIROMETER, MONITORING W/ALARM
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BZK
1978-01-26
RESPITRACE
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BZK
1977-07-05
SPIROMETEO EXHAUST
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BZK
1976-12-09
POSITIVE DISPLACEMENT SPIROMETER
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