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FDA 510(k)

DUAL-TEMP(TM) COOLING/WARMING UNIT

K-Number: K882310 · 1988-09-23

ApplicantSeabrook Medical Systems, Inc.
Decision Date1988-09-23
Product CodeILO
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

DUAL-TEMP(TM) COOLING/WARMING UNIT is the device name listed in this FDA 510(k) record. The listed applicant is Seabrook Medical Systems, Inc.. It received FDA 510(k) clearance on 1988-09-23 under 510(k) number K882310. The device is classified under product code ILO. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DUAL-TEMP(TM) COOLING/WARMING UNIT?

DUAL-TEMP(TM) COOLING/WARMING UNIT is a medical device that received FDA 510(k) clearance on 1988-09-23. The listed applicant is Seabrook Medical Systems, Inc.. The 510(k) number is K882310.

When did DUAL-TEMP(TM) COOLING/WARMING UNIT receive FDA 510(k) clearance?

DUAL-TEMP(TM) COOLING/WARMING UNIT received FDA 510(k) clearance on 1988-09-23, under 510(k) number K882310.

Who is the listed applicant for DUAL-TEMP(TM) COOLING/WARMING UNIT?

The FDA 510(k) record lists Seabrook Medical Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DUAL-TEMP(TM) COOLING/WARMING UNIT?

The FDA product code for DUAL-TEMP(TM) COOLING/WARMING UNIT is ILO.

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Other records listing Seabrook Medical Systems, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K952086TROPICAIR CONVECTIVE WARMING BLANKETSK946196TROPICAIR CONVECTIVE WARING SYSTEMK931203COOL-AIDK923104TROPIC-AIRK914182GOLDEN THERMAL(R)K902756TROPI-COOL

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Related Devices (Code: ILO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K213097Armory MotionPain Management Technologies, Inc.K083008COOLSKINElbio Co., Ltd.K073675T-PUMP LOCALIZED TEMPERATURE THERAPY PUMPGaymar Industries, Inc.K072152JUNIPER CLN1 DERMAL COOLING DEVICEJuniper Medical, Inc.K070402MODIFICATION TO POLAR CARE 500Breg, Inc.K040317IVC SYSTEMMark H. Friedman

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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