Device Classification Name |
Ventilatory Effort Recorder
|
510(k) Number |
K183625 |
Device Name |
SomnaPatch |
Applicant |
Respironics, Inc. |
1001 Murry Ridge Lane |
Murrysville,
PA
15668
|
|
Applicant Contact |
Amy Panzik |
Correspondent |
Respironics, Inc. |
1740 Golden Mile Highway |
Monroeville,
PA
15146
|
|
Correspondent Contact |
Amy Panzik |
Regulation Number | 868.2375
|
Classification Product Code |
|
Date Received | 12/26/2018 |
Decision Date | 10/18/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Clinical Trials |
NCT02034175
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|