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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 a medical device manufactured by Respironics, Inc.. It received FDA 510(k) clearance on 2020-10-29 under approval 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. It is manufactured by Respironics, Inc.. The 510(k) number is K202142.

When was Sleepware G3 approved by the FDA?

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

What company makes Sleepware G3?

Sleepware G3 is manufactured by Respironics, Inc..

What is the FDA product code for Sleepware G3?

The FDA product code for Sleepware G3 is OLZ.

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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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