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FDA 510(k)

TRU-5000 THERMAL RECOVERY RADIANT HEATING UNIT

K-Number: K963731 · 1997-04-22

ApplicantEnthermics Medical Systems, Inc.
Decision Date1997-04-22
Product CodeDWJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TRU-5000 THERMAL RECOVERY RADIANT HEATING UNIT is the device name listed in this FDA 510(k) record. The listed applicant is Enthermics Medical Systems, Inc.. It received FDA 510(k) clearance on 1997-04-22 under 510(k) number K963731. 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 TRU-5000 THERMAL RECOVERY RADIANT HEATING UNIT?

TRU-5000 THERMAL RECOVERY RADIANT HEATING UNIT is a medical device that received FDA 510(k) clearance on 1997-04-22. The listed applicant is Enthermics Medical Systems, Inc.. The 510(k) number is K963731.

When did TRU-5000 THERMAL RECOVERY RADIANT HEATING UNIT receive FDA 510(k) clearance?

TRU-5000 THERMAL RECOVERY RADIANT HEATING UNIT received FDA 510(k) clearance on 1997-04-22, under 510(k) number K963731.

Who is the listed applicant for TRU-5000 THERMAL RECOVERY RADIANT HEATING UNIT?

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

What is the FDA product code for TRU-5000 THERMAL RECOVERY RADIANT HEATING UNIT?

The FDA product code for TRU-5000 THERMAL RECOVERY RADIANT HEATING UNIT is DWJ.

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Other records listing Enthermics 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.

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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

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

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