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FDA 510(k)

HOT DOG PATIENT WARMING MATTRESS SYSTEM, MODELS WCUB, M101, M102 AND M103

K-Number: K092807 · 2009-12-10

ApplicantAugustine Biomedical & Design, LLC
Decision Date2009-12-10
Product CodeDWJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HOT DOG PATIENT WARMING MATTRESS SYSTEM, MODELS WCUB, M101, M102 AND M103 is the device name listed in this FDA 510(k) record. The listed applicant is Augustine Biomedical & Design, LLC. It received FDA 510(k) clearance on 2009-12-10 under 510(k) number K092807. 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 HOT DOG PATIENT WARMING MATTRESS SYSTEM, MODELS WCUB, M101, M102 AND M103?

HOT DOG PATIENT WARMING MATTRESS SYSTEM, MODELS WCUB, M101, M102 AND M103 is a medical device that received FDA 510(k) clearance on 2009-12-10. The listed applicant is Augustine Biomedical & Design, LLC. The 510(k) number is K092807.

When did HOT DOG PATIENT WARMING MATTRESS SYSTEM, MODELS WCUB, M101, M102 AND M103 receive FDA 510(k) clearance?

HOT DOG PATIENT WARMING MATTRESS SYSTEM, MODELS WCUB, M101, M102 AND M103 received FDA 510(k) clearance on 2009-12-10, under 510(k) number K092807.

Who is the listed applicant for HOT DOG PATIENT WARMING MATTRESS SYSTEM, MODELS WCUB, M101, M102 AND M103?

The FDA 510(k) record lists Augustine Biomedical & Design, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HOT DOG PATIENT WARMING MATTRESS SYSTEM, MODELS WCUB, M101, M102 AND M103?

The FDA product code for HOT DOG PATIENT WARMING MATTRESS SYSTEM, MODELS WCUB, M101, M102 AND M103 is DWJ.

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Other records listing Augustine Biomedical & Design, LLC 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.

K112488HOTDOG PATIENT WARMING SYSTEMK094056HOTDOG MULTI FUNCTION CONTROLLERK052392HOT DOG PATIENT WARMING SYSTEM

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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