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FDA 510(k)

The iNAP One Sleep Therapy System

K-Number: K193460 · 2020-05-26

ApplicantSomnice, Inc.
Decision Date2020-05-26
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 Somnice, Inc.. It received FDA 510(k) clearance on 2020-05-26 under 510(k) number K193460. 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 2020-05-26. The listed applicant is Somnice, Inc.. The 510(k) number is K193460.

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 2020-05-26, under 510(k) number K193460.

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

The FDA 510(k) record lists Somnice, 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.

Related Devices (Code: OZR)

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.

K220907The iNAP One Sleep Therapy SystemSomnics, 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.

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