Device Classification Name |
sleep appliances with patient monitoring
|
510(k) Number |
K172859 |
Device Name |
Prosomnus [CA] Sleep and Snore Device and Prosomnus [CA] Sleep and Snore Device with Micro-recorder |
Applicant |
Prosomnous Sleep Technologies |
5860 W. Las Positas Blvd., Suite 25 |
Pleasanton,
CA
94588
|
|
Applicant Contact |
David Kuhns |
Correspondent |
Prosomnous Sleep Technologies |
5860 W. Las Positas Blvd., Suite 25 |
Pleasanton,
CA
94588
|
|
Correspondent Contact |
David Kuhns |
Regulation Number | 872.5570
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 09/20/2017 |
Decision Date | 11/22/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|