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FDA 510(k)

RK2000 K-THERMIA SYSTEM

K-Number: K882442 · 1988-09-06

ApplicantBaxter Healthcare Corp
Decision Date1988-09-06
Product CodeDWJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

RK2000 K-THERMIA SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Baxter Healthcare Corp. It received FDA 510(k) clearance on 1988-09-06 under 510(k) number K882442. 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 RK2000 K-THERMIA SYSTEM?

RK2000 K-THERMIA SYSTEM is a medical device that received FDA 510(k) clearance on 1988-09-06. The listed applicant is Baxter Healthcare Corp. The 510(k) number is K882442.

When did RK2000 K-THERMIA SYSTEM receive FDA 510(k) clearance?

RK2000 K-THERMIA SYSTEM received FDA 510(k) clearance on 1988-09-06, under 510(k) number K882442.

Who is the listed applicant for RK2000 K-THERMIA SYSTEM?

The FDA 510(k) record lists Baxter Healthcare Corp as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RK2000 K-THERMIA SYSTEM?

The FDA product code for RK2000 K-THERMIA SYSTEM is DWJ.

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Other records listing Baxter Healthcare Corp as applicant

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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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