Device Classification Name |
Ventilator, Non-Continuous (Respirator)
|
510(k) Number |
K132168 |
Device Name |
BRONCHOSCOPY ELBOW |
Applicant |
RESPIRONICS, INC. |
365 PLUM INDUSTRIAL COURT |
PITTSBURGH,
PA
15239
|
|
Applicant Contact |
COLLEEN WITT |
Correspondent |
RESPIRONICS, INC. |
365 PLUM INDUSTRIAL COURT |
PITTSBURGH,
PA
15239
|
|
Correspondent Contact |
COLLEEN WITT |
Regulation Number | 868.5905
|
Classification Product Code |
|
Date Received | 07/12/2013 |
Decision Date | 11/20/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|