| Device Classification Name |
Meter, Airway Pressure (Inspiratory Force)
|
| 510(k) Number |
K901998 |
| Device Name |
DIGITAL MANOMETER (DM 50) |
| Applicant |
| Medical Support Products, Inc. |
| 3401 Charlestown Rd. |
|
Lancaster,
PA
17603
|
|
| Applicant Contact |
NELSON SHERTZER |
| Correspondent |
| Medical Support Products, Inc. |
| 3401 Charlestown Rd. |
|
Lancaster,
PA
17603
|
|
| Correspondent Contact |
NELSON SHERTZER |
| Regulation Number | 868.1780 |
| Classification Product Code |
|
| Date Received | 05/02/1990 |
| Decision Date | 07/25/1990 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Anesthesiology
|
| 510k Review Panel |
Anesthesiology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|