Device Classification Name |
cuff, tracheal tube, inflatable
|
510(k) Number |
K833327 |
Device Name |
RESPIRONICS PR VALVE |
Applicant |
RESPIRONICS, INC. |
530 SECO RD. |
MONROEVILLE,
PA
15146
|
|
Correspondent |
RESPIRONICS, INC. |
530 SECO RD. |
MONROEVILLE,
PA
15146
|
|
Regulation Number | 868.5750
|
Classification Product Code |
|
Date Received | 09/27/1983 |
Decision Date | 11/28/1983 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|