| Device Classification Name |
Tubing, Pressure And Accessories
|
| 510(k) Number |
K811551 |
| Device Name |
TIMETER PRODUCED OHIO OXYGEN ADAPTOR |
| Applicant |
| Timeter Instrument Corp. |
| 4221 Richmond Rd., NW |
|
Walker,
MI
49534
|
|
| Correspondent |
| Timeter Instrument Corp. |
| 4221 Richmond Rd., NW |
|
Walker,
MI
49534
|
|
| Regulation Number | 868.5860 |
| Classification Product Code |
|
| Date Received | 06/02/1981 |
| Decision Date | 06/18/1981 |
| 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
|
|
|