| Device Classification Name |
Gauge, Gas Pressure, Cylinder/Pipeline
|
| 510(k) Number |
K853040 |
| Device Name |
PRESSURE GAUGE |
| Applicant |
| ERIE MEDICAL |
| 4000 SOUTH 13TH ST. |
|
MILWAUKEE,
WI
53221
|
|
| Applicant Contact |
STEVEN A CASE |
| Correspondent |
| ERIE MEDICAL |
| 4000 SOUTH 13TH ST. |
|
MILWAUKEE,
WI
53221
|
|
| Correspondent Contact |
STEVEN A CASE |
| Regulation Number | 868.2610 |
| Classification Product Code |
|
| Date Received | 07/19/1985 |
| Decision Date | 10/10/1985 |
| 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
|
|
|