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FDA 510(k)

HOTDOG PATIENT WARMING SYSTEM

K-Number: K112488 · 2011-11-23

ApplicantAugustine Biomedical & Design, LLC
Decision Date2011-11-23
Product CodeDWJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HOTDOG PATIENT WARMING SYSTEM 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 2011-11-23 under 510(k) number K112488. 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 HOTDOG PATIENT WARMING SYSTEM?

HOTDOG PATIENT WARMING SYSTEM is a medical device that received FDA 510(k) clearance on 2011-11-23. The listed applicant is Augustine Biomedical & Design, LLC. The 510(k) number is K112488.

When did HOTDOG PATIENT WARMING SYSTEM receive FDA 510(k) clearance?

HOTDOG PATIENT WARMING SYSTEM received FDA 510(k) clearance on 2011-11-23, under 510(k) number K112488.

Who is the listed applicant for HOTDOG PATIENT WARMING SYSTEM?

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 HOTDOG PATIENT WARMING SYSTEM?

The FDA product code for HOTDOG PATIENT WARMING SYSTEM is DWJ.

Related Clinical Trials

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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.

K094056HOTDOG MULTI FUNCTION CONTROLLERK092807HOT DOG PATIENT WARMING MATTRESS SYSTEM, MODELS WCUB, M101, M102 AND M103K052392HOT 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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