Device Classification Name |
cuff, tracheal tube, inflatable
|
510(k) Number |
K923800 |
Device Name |
PRESSURE GAUGE |
Applicant |
INNOVATIONS FOR MECHANICAL VENTILATION, INC. |
8 AMHERST RD. |
NEW CITY,
NY
10956
|
|
Applicant Contact |
RALPH A MILLIKEN |
Correspondent |
INNOVATIONS FOR MECHANICAL VENTILATION, INC. |
8 AMHERST RD. |
NEW CITY,
NY
10956
|
|
Correspondent Contact |
RALPH A MILLIKEN |
Regulation Number | 868.5750
|
Classification Product Code |
|
Date Received | 07/29/1992 |
Decision Date | 02/26/1993 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|