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FDA 510(k)

SomnoMetry

K-Number: K221179 · 2022-09-21

Decision Date2022-09-21
Product CodeOLZ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

SomnoMetry is a medical device manufactured by Neumetry Medical, Inc.. It received FDA 510(k) clearance on 2022-09-21 under approval number K221179. The device is classified under product code OLZ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SomnoMetry?

SomnoMetry is a medical device that received FDA 510(k) clearance on 2022-09-21. It is manufactured by Neumetry Medical, Inc.. The 510(k) number is K221179.

When was SomnoMetry approved by the FDA?

SomnoMetry received FDA 510(k) clearance on 2022-09-21, under approval number K221179.

What company makes SomnoMetry?

SomnoMetry is manufactured by Neumetry Medical, Inc..

What is the FDA product code for SomnoMetry?

The FDA product code for SomnoMetry is OLZ.

Related Devices (Code: OLZ)

Official Source

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