Prosomnus [CA] Sleep and Snore Device and Prosomnus [CA] Sleep and Snore Device with Micro-recorder— 510(k) K172859

Name: FDA 510(k) clearance K172859
Creator: U.S. Food and Drug Administration
Published: 2017-11-22

Substantially Equivalent

Prosomnous Sleep Technologies

FDA 510(k) clearance K172859 for Prosomnus [CA] Sleep and Snore Device and Prosomnus [CA] Sleep and Snore Device with Micro-recorder, Substantially Equivalent on 2017-11-22. Applicant: Prosomnous Sleep Technologies. Device class: 2.

Clearance details

Applicant: Prosomnous Sleep Technologies
Product code: Code PLC
Device class: Class 2
Regulation: 21 CFR 872.5570
Advisory panel: Dental
Date received: 2017-09-20
Decision date: 2017-11-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pleasanton, CA, US

Download summary PDF View on FDA.gov ↗

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