Device Classification Name |
Percussor, Powered-Electric
|
510(k) Number |
K133057 |
Device Name |
VIBRALUNG ACOUSTICAL PERCUSSOR |
Applicant |
Westmed, Inc. |
5580 S. NOGALES HIGHWAY |
TUCSON,
AZ
85706
|
|
Applicant Contact |
PAUL DRYDEN |
Correspondent |
Westmed, Inc. |
5580 S. NOGALES HIGHWAY |
TUCSON,
AZ
85706
|
|
Correspondent Contact |
PAUL DRYDEN |
Regulation Number | 868.5665
|
Classification Product Code |
|
Date Received | 09/27/2013 |
Decision Date | 05/23/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|