Device Classification Name |
Spirometer, Therapeutic (Incentive)
|
510(k) Number |
K153441 |
Device Name |
VibraPEP |
Applicant |
Medica Holdings, LLC |
5200 Meadows Road, Suite 150 |
Lake Oswego,
OR
97035
|
|
Applicant Contact |
George Reed |
Correspondent |
Medica Holdings, LLC |
5200 Meadows Road, Suite 150 |
Lake Oswego,
OR
97035
|
|
Correspondent Contact |
Paul Dryden |
Regulation Number | 868.5690
|
Classification Product Code |
|
Date Received | 11/27/2015 |
Decision Date | 03/25/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|