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.
Device ID | K172859 |
510k Number | K172859 |
Device Name: | Prosomnus [CA] Sleep And Snore Device And Prosomnus [CA] Sleep And Snore Device With Micro-recorder |
Classification | Sleep Appliances With Patient Monitoring |
Applicant | Prosomnous Sleep Technologies 5860 W. Las Positas Blvd., Suite 25 Pleasanton, CA 94588 |
Contact | David Kuhns |
Correspondent | David Kuhns Prosomnous Sleep Technologies 5860 W. Las Positas Blvd., Suite 25 Pleasanton, CA 94588 |
Product Code | PLC |
CFR Regulation Number | 872.5570 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-09-20 |
Decision Date | 2017-11-22 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00863039000454 | K172859 | 000 |
00863039000409 | K172859 | 000 |