FDA 510(k)

NIO-P

K-Number: K160805 · 2016-06-23

Decision Date2016-06-23

Product CodeFMI

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

NIO-P is a medical device manufactured by Waismed, Ltd.. It received FDA 510(k) clearance on 2016-06-23 under approval number K160805. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NIO-P?

NIO-P is a medical device that received FDA 510(k) clearance on 2016-06-23. It is manufactured by Waismed, Ltd.. The 510(k) number is K160805.

When was NIO-P approved by the FDA?

NIO-P received FDA 510(k) clearance on 2016-06-23, under approval number K160805.

What company makes NIO-P?

NIO-P is manufactured by Waismed, Ltd..

What is the FDA product code for NIO-P?

The FDA product code for NIO-P is FMI.

Other Devices by Waismed, Ltd.

K190538NIO-I K211968NIO+ Adult

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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.