FDA 510(k)

The iNAP One Sleep Therapy System

K-Number: K220907 · 2023-06-16

Decision Date2023-06-16

Product CodeOZR

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

The iNAP One Sleep Therapy System is the device name listed in this FDA 510(k) record. The listed applicant is Somnics, Inc.. It received FDA 510(k) clearance on 2023-06-16 under 510(k) number K220907. The device is classified under product code OZR. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the The iNAP One Sleep Therapy System?

The iNAP One Sleep Therapy System is a medical device that received FDA 510(k) clearance on 2023-06-16. The listed applicant is Somnics, Inc.. The 510(k) number is K220907.

When did The iNAP One Sleep Therapy System receive FDA 510(k) clearance?

The iNAP One Sleep Therapy System received FDA 510(k) clearance on 2023-06-16, under 510(k) number K220907.

Who is the listed applicant for The iNAP One Sleep Therapy System?

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

What is the FDA product code for The iNAP One Sleep Therapy System?

The FDA product code for The iNAP One Sleep Therapy System is OZR.

Other records listing Somnics, Inc. as applicant

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.

K152660HYPNOSPAD

Related Devices (Code: OZR)

K193460The iNAP One Sleep Therapy SystemSomnice, Inc.

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.