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FDA 510(k)

IOB Warming Blankets

K-Number: K221669 · 2022-12-27

ApplicantIob Medical, Inc.
Decision Date2022-12-27
Product CodeDWJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

IOB Warming Blankets is the device name listed in this FDA 510(k) record. The listed applicant is Iob Medical, Inc.. It received FDA 510(k) clearance on 2022-12-27 under 510(k) number K221669. 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 IOB Warming Blankets?

IOB Warming Blankets is a medical device that received FDA 510(k) clearance on 2022-12-27. The listed applicant is Iob Medical, Inc.. The 510(k) number is K221669.

When did IOB Warming Blankets receive FDA 510(k) clearance?

IOB Warming Blankets received FDA 510(k) clearance on 2022-12-27, under 510(k) number K221669.

Who is the listed applicant for IOB Warming Blankets?

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

What is the FDA product code for IOB Warming Blankets?

The FDA product code for IOB Warming Blankets is DWJ.

Other records listing Iob Medical, Inc. 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.

K232638FilteredFlo Warming BlanketsK231596IOB Temperature Management SystemK201896ivi N3003 Surgical face Mask, ivi N6006 Surgical maskK190221IOB Warming BlanketsK162679IOB Temperature Management 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.

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.K242964Celsi WarmerHadleigh Health Technologies

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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