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FDA 510(k)

LIFE-AIR 1000 HYPOTHERMIC TREATMENT SYSTEM

K-Number: K914382 · 1992-04-21

ApplicantProgressive Dynamics, Inc.
Decision Date1992-04-21
Product CodeDWJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

LIFE-AIR 1000 HYPOTHERMIC TREATMENT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Progressive Dynamics, Inc.. It received FDA 510(k) clearance on 1992-04-21 under 510(k) number K914382. 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 LIFE-AIR 1000 HYPOTHERMIC TREATMENT SYSTEM?

LIFE-AIR 1000 HYPOTHERMIC TREATMENT SYSTEM is a medical device that received FDA 510(k) clearance on 1992-04-21. The listed applicant is Progressive Dynamics, Inc.. The 510(k) number is K914382.

When did LIFE-AIR 1000 HYPOTHERMIC TREATMENT SYSTEM receive FDA 510(k) clearance?

LIFE-AIR 1000 HYPOTHERMIC TREATMENT SYSTEM received FDA 510(k) clearance on 1992-04-21, under 510(k) number K914382.

Who is the listed applicant for LIFE-AIR 1000 HYPOTHERMIC TREATMENT SYSTEM?

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

What is the FDA product code for LIFE-AIR 1000 HYPOTHERMIC TREATMENT SYSTEM?

The FDA product code for LIFE-AIR 1000 HYPOTHERMIC TREATMENT SYSTEM is DWJ.

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Other records listing Progressive Dynamics, 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.

K952329LIFE-AIR 1000 HYPOTHERMIC THERAPY SYSTEMK944688LUMINOUS 150 DUAL LAMPFIBEROPTIC ILLUMINATORK933764LIFE-AIR 1000 PATIENT WARMING COVERK933593LUMINOUS 150 FIBEROPTIC ILLUMINATORK921866LUMINOUS 250 FIBEROPTIC ILLUMINATORK914383LIFE-AIR 1000 PATIENT WARMING COVERS

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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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