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FDA 510(k)

Sleepware G3

K-Number: K202142 · 2020-10-29

ApplicantRespironics, Inc.
Decision Date2020-10-29
Product CodeOLZ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Sleepware G3 is the device name listed in this FDA 510(k) record. The listed applicant is Respironics, Inc.. It received FDA 510(k) clearance on 2020-10-29 under 510(k) number K202142. 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 Sleepware G3?

Sleepware G3 is a medical device that received FDA 510(k) clearance on 2020-10-29. The listed applicant is Respironics, Inc.. The 510(k) number is K202142.

When did Sleepware G3 receive FDA 510(k) clearance?

Sleepware G3 received FDA 510(k) clearance on 2020-10-29, under 510(k) number K202142.

Who is the listed applicant for Sleepware G3?

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

What is the FDA product code for Sleepware G3?

The FDA product code for Sleepware G3 is OLZ.

Other records listing Respironics, Inc. as applicant

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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 EhfK250058NEAT 001Brain Electrophysiology Laboratory Company, LLCK241960DeepRESPNox Medical Ehf

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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