Prosomnus [CA] Sleep And Snore Device And Prosomnus [CA] Sleep And Snore Device With Micro-recorder

Sleep Appliances With Patient Monitoring

Prosomnous Sleep Technologies

The following data is part of a premarket notification filed by Prosomnous Sleep Technologies with the FDA for Prosomnus [ca] Sleep And Snore Device And Prosomnus [ca] Sleep And Snore Device With Micro-recorder.

Pre-market Notification Details

Device IDK172859
510k NumberK172859
Device Name:Prosomnus [CA] Sleep And Snore Device And Prosomnus [CA] Sleep And Snore Device With Micro-recorder
ClassificationSleep Appliances With Patient Monitoring
Applicant Prosomnous Sleep Technologies 5860 W. Las Positas Blvd., Suite 25 Pleasanton,  CA  94588
ContactDavid Kuhns
CorrespondentDavid Kuhns
Prosomnous Sleep Technologies 5860 W. Las Positas Blvd., Suite 25 Pleasanton,  CA  94588
Product CodePLC  
CFR Regulation Number872.5570 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-09-20
Decision Date2017-11-22
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00863039000454 K172859 000
00863039000409 K172859 000

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