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FDA 510(k)

IOB Temperature Management System

K-Number: K162679 · 2017-04-28

Decision Date2017-04-28
Product CodeDWJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

IOB Temperature Management System is a medical device manufactured by Iob Medical, Inc.. It received FDA 510(k) clearance on 2017-04-28 under approval number K162679. 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 Temperature Management System?

IOB Temperature Management System is a medical device that received FDA 510(k) clearance on 2017-04-28. It is manufactured by Iob Medical, Inc.. The 510(k) number is K162679.

When was IOB Temperature Management System approved by the FDA?

IOB Temperature Management System received FDA 510(k) clearance on 2017-04-28, under approval number K162679.

What company makes IOB Temperature Management System?

IOB Temperature Management System is manufactured by Iob Medical, Inc..

What is the FDA product code for IOB Temperature Management System?

The FDA product code for IOB Temperature Management System is DWJ.

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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.