| Device Classification Name |
Gas, Calibration (Specified Concentration)
|
| 510(k) Number |
K870139 |
| Device Name |
GAS, CALIBRATION, SPECIFIED CONCENTRATION |
| Applicant |
| Portland Welding Supply, Inc. |
| 527 Danforth St. |
| P.O. Box 8361 |
|
Portland,
ME
04104
|
|
| Applicant Contact |
DIANE BRANSCOMB |
| Correspondent |
| Portland Welding Supply, Inc. |
| 527 Danforth St. |
| P.O. Box 8361 |
|
Portland,
ME
04104
|
|
| Correspondent Contact |
DIANE BRANSCOMB |
| Regulation Number | 868.6400 |
| Classification Product Code |
|
| Date Received | 01/13/1987 |
| Decision Date | 02/10/1987 |
| 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
|
|
|