FDA 510(k)

Insufflator 50L FM134

K-Number: K153513 · 2016-03-04

Decision Date2016-03-04

Product CodeHIF

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

Insufflator 50L FM134 is a medical device manufactured by W.O.M. World of Medicine GmbH. It received FDA 510(k) clearance on 2016-03-04 under approval number K153513. The device is classified under product code HIF. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Insufflator 50L FM134?

Insufflator 50L FM134 is a medical device that received FDA 510(k) clearance on 2016-03-04. It is manufactured by W.O.M. World of Medicine GmbH. The 510(k) number is K153513.

When was Insufflator 50L FM134 approved by the FDA?

Insufflator 50L FM134 received FDA 510(k) clearance on 2016-03-04, under approval number K153513.

What company makes Insufflator 50L FM134?

Insufflator 50L FM134 is manufactured by W.O.M. World of Medicine GmbH.

What is the FDA product code for Insufflator 50L FM134?

The FDA product code for Insufflator 50L FM134 is HIF.

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Related Devices (Code: HIF)

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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.