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FDA 510(k)

WARMTOUCH PATIENT WARMING SYSTEM, MODEL 5300

K-Number: K020604 · 2002-04-23

ApplicantNellcor Puritan Bennett, Inc.
Decision Date2002-04-23
Product CodeDWJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

WARMTOUCH PATIENT WARMING SYSTEM, MODEL 5300 is the device name listed in this FDA 510(k) record. The listed applicant is Nellcor Puritan Bennett, Inc.. It received FDA 510(k) clearance on 2002-04-23 under 510(k) number K020604. 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 WARMTOUCH PATIENT WARMING SYSTEM, MODEL 5300?

WARMTOUCH PATIENT WARMING SYSTEM, MODEL 5300 is a medical device that received FDA 510(k) clearance on 2002-04-23. The listed applicant is Nellcor Puritan Bennett, Inc.. The 510(k) number is K020604.

When did WARMTOUCH PATIENT WARMING SYSTEM, MODEL 5300 receive FDA 510(k) clearance?

WARMTOUCH PATIENT WARMING SYSTEM, MODEL 5300 received FDA 510(k) clearance on 2002-04-23, under 510(k) number K020604.

Who is the listed applicant for WARMTOUCH PATIENT WARMING SYSTEM, MODEL 5300?

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

What is the FDA product code for WARMTOUCH PATIENT WARMING SYSTEM, MODEL 5300?

The FDA product code for WARMTOUCH PATIENT WARMING SYSTEM, MODEL 5300 is DWJ.

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Other records listing Nellcor Puritan Bennett, Inc. 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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