| Device Classification Name |
Generator, Oxygen, Portable
|
| 510(k) Number |
K873526 |
| Device Name |
PALL FIELD MEDICAL OXYGEN GENERA. & DISTRI. SYSTEM |
| Applicant |
| Pall Safety Atmospheres, Inc. |
| 316 SW 33rd Ave. |
|
Ocala,
FL
32674
|
|
| Applicant Contact |
TED SHEPPERS |
| Correspondent |
| Pall Safety Atmospheres, Inc. |
| 316 SW 33rd Ave. |
|
Ocala,
FL
32674
|
|
| Correspondent Contact |
TED SHEPPERS |
| Regulation Number | 868.5440 |
| Classification Product Code |
|
| Date Received | 09/01/1987 |
| Decision Date | 02/29/1988 |
| 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
|
|
|