Device Classification Name |
Percussor, Powered-Electric
|
510(k) Number |
K122111 |
Device Name |
RESPIRONICS SIMPLYCLEAR DEVICE |
Applicant |
RESPIRONICS, INC. |
1740 GOLDEN MILE HIGHWAY |
MONROEVILLE,
PA
15146
|
|
Applicant Contact |
COLLEEN WITT |
Correspondent |
RESPIRONICS, INC. |
1740 GOLDEN MILE HIGHWAY |
MONROEVILLE,
PA
15146
|
|
Correspondent Contact |
COLLEEN WITT |
Regulation Number | 868.5665
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 07/17/2012 |
Decision Date | 12/31/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|