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FDA 510(k)

HOTDOG MULTI FUNCTION CONTROLLER

K-Number: K094056 · 2010-06-03

ApplicantAugustine Biomedical & Design, LLC
Decision Date2010-06-03
Product CodeDWJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HOTDOG MULTI FUNCTION CONTROLLER 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 2010-06-03 under 510(k) number K094056. 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 MULTI FUNCTION CONTROLLER?

HOTDOG MULTI FUNCTION CONTROLLER is a medical device that received FDA 510(k) clearance on 2010-06-03. The listed applicant is Augustine Biomedical & Design, LLC. The 510(k) number is K094056.

When did HOTDOG MULTI FUNCTION CONTROLLER receive FDA 510(k) clearance?

HOTDOG MULTI FUNCTION CONTROLLER received FDA 510(k) clearance on 2010-06-03, under 510(k) number K094056.

Who is the listed applicant for HOTDOG MULTI FUNCTION CONTROLLER?

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 MULTI FUNCTION CONTROLLER?

The FDA product code for HOTDOG MULTI FUNCTION CONTROLLER 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 SYSTEMK092807HOT 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

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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