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FDA 510(k)

SOFT AIR, MODEL SA 4000 AND MISTRAL AIR, MODEL MA0100

K-Number: K073712 · 2008-06-06

ApplicantAdroit Medical Systems, Inc.
Decision Date2008-06-06
Product CodeDWJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SOFT AIR, MODEL SA 4000 AND MISTRAL AIR, MODEL MA0100 is the device name listed in this FDA 510(k) record. The listed applicant is Adroit Medical Systems, Inc.. It received FDA 510(k) clearance on 2008-06-06 under 510(k) number K073712. 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 SOFT AIR, MODEL SA 4000 AND MISTRAL AIR, MODEL MA0100?

SOFT AIR, MODEL SA 4000 AND MISTRAL AIR, MODEL MA0100 is a medical device that received FDA 510(k) clearance on 2008-06-06. The listed applicant is Adroit Medical Systems, Inc.. The 510(k) number is K073712.

When did SOFT AIR, MODEL SA 4000 AND MISTRAL AIR, MODEL MA0100 receive FDA 510(k) clearance?

SOFT AIR, MODEL SA 4000 AND MISTRAL AIR, MODEL MA0100 received FDA 510(k) clearance on 2008-06-06, under 510(k) number K073712.

Who is the listed applicant for SOFT AIR, MODEL SA 4000 AND MISTRAL AIR, MODEL MA0100?

The FDA 510(k) record lists Adroit Medical Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SOFT AIR, MODEL SA 4000 AND MISTRAL AIR, MODEL MA0100?

The FDA product code for SOFT AIR, MODEL SA 4000 AND MISTRAL AIR, MODEL MA0100 is DWJ.

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Other records listing Adroit Medical Systems, 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

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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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