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FDA 510(k)

TROPICAIR CONVECTIVE WARING SYSTEM

K-Number: K946196 · 1995-09-06

ApplicantSeabrook Medical Systems, Inc.
Decision Date1995-09-06
Product CodeDWJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TROPICAIR CONVECTIVE WARING SYSTEM 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 1995-09-06 under 510(k) number K946196. The device is classified under product code DWJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TROPICAIR CONVECTIVE WARING SYSTEM?

TROPICAIR CONVECTIVE WARING SYSTEM is a medical device that received FDA 510(k) clearance on 1995-09-06. The listed applicant is Seabrook Medical Systems, Inc.. The 510(k) number is K946196.

When did TROPICAIR CONVECTIVE WARING SYSTEM receive FDA 510(k) clearance?

TROPICAIR CONVECTIVE WARING SYSTEM received FDA 510(k) clearance on 1995-09-06, under 510(k) number K946196.

Who is the listed applicant for TROPICAIR CONVECTIVE WARING SYSTEM?

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 TROPICAIR CONVECTIVE WARING SYSTEM?

The FDA product code for TROPICAIR CONVECTIVE WARING SYSTEM is DWJ.

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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 BLANKETSK931203COOL-AIDK923104TROPIC-AIRK914182GOLDEN THERMAL(R)K902756TROPI-COOLK902269ELECTRI-COOL(TM) LIQUID-CIRCULAT. THERMAL THERAPY

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Related Devices (Code: DWJ)

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.

K262089Disposable Warming BlanketHangzhou Tappa Medical Technology Co., Ltd.K261437Mistral-Air® Warming SystemThe Surgical Company International B.V., doing business as TSC LifeK260278ThermAffyx(TM) Patient Safety SystemStihler Electronic GmbHK260903Hot Pink Pad Warming SystemXodus Medical, Inc.K252861Warming SystemHangzhou Tappa Medical Technology Co., Ltd.K251974Arctic Sun Temperature Management System (Model 5000)Medivance, Inc.

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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