| Device Classification Name |
Regulator, Pressure, Gas Cylinder
|
| 510(k) Number |
K932006 |
| Device Name |
1500 SERIES REGULATOR |
| Applicant |
| Precision Medical, Inc. |
| 300 Held Dr. |
|
Northampton,
PA
18067
|
|
| Applicant Contact |
JOHN R SELADY |
| Correspondent |
| Precision Medical, Inc. |
| 300 Held Dr. |
|
Northampton,
PA
18067
|
|
| Correspondent Contact |
JOHN R SELADY |
| Regulation Number | 868.2700 |
| Classification Product Code |
|
| Date Received | 04/21/1993 |
| Decision Date | 10/25/1993 |
| 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
|
|
|