FDA 510(k)

IOB Warming Blankets

K-Number: K190221 · 2019-10-25

Decision Date2019-10-25

Product CodeDWJ

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

IOB Warming Blankets is a medical device manufactured by Iob Medical, Inc.. It received FDA 510(k) clearance on 2019-10-25 under approval number K190221. 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 2019-10-25. It is manufactured by Iob Medical, Inc.. The 510(k) number is K190221.

When was IOB Warming Blankets approved by the FDA?

IOB Warming Blankets received FDA 510(k) clearance on 2019-10-25, under approval number K190221.

What company makes IOB Warming Blankets?

IOB Warming Blankets is manufactured by Iob Medical, Inc..

What is the FDA product code for IOB Warming Blankets?

The FDA product code for IOB Warming Blankets is DWJ.

Other Devices by Iob Medical, Inc.

K162679IOB Temperature Management System K201896ivi N3003 Surgical face Mask, ivi N6006 Surgical mask K221669IOB Warming Blankets K232638FilteredFlo Warming Blankets K231596IOB Temperature Management System

Related Devices (Code: DWJ)

K152266Altrix Precision Temperature Management SystemStryker Medical K161602Arctic Sun Temperature Management SystemMedivance, Inc. K1713733M Bair Hugger Model 675 Total Temperature Management System3M Company K171149Altrix Temperature Management WrapsStryker Medical K171234Mistral-Air Warming UnitThe Surgical Company International BV (As the 37company) K162679IOB Temperature Management SystemIob Medical, 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.