FDA 510(k)

SomnoMetry

K-Number: K221179 · 2022-09-21

Decision Date2022-09-21

Product CodeOLZ

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

SomnoMetry is the device name listed in this FDA 510(k) record. The listed applicant is Neumetry Medical, Inc.. It received FDA 510(k) clearance on 2022-09-21 under 510(k) 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. The listed applicant is Neumetry Medical, Inc.. The 510(k) number is K221179.

When did SomnoMetry receive FDA 510(k) clearance?

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

Who is the listed applicant for SomnoMetry?

The FDA 510(k) record lists Neumetry Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SomnoMetry?

The FDA product code for SomnoMetry is OLZ.

Related Devices (Code: OLZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253390SOMNUM (SOMNUM)Honeynaps Co., Ltd.K253668Onera SleepMap (SLEEPMAP)Onera B.V.K250851Hypnos (369054-200)Cadwell Industries, Inc.K252330DeepRESPNox Medical Ehf K250058NEAT 001Brain Electrophysiology Laboratory Company, LLC K241960DeepRESPNox Medical Ehf

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.