| Device Classification Name |
Gas-Machine, Anesthesia
|
| 510(k) Number |
K884879 |
| Device Name |
CENTURION(TM) MIXER |
| Applicant |
| Matrix Medica, Inc. |
| 145 Mid County Dr. |
|
Orchard Park,
NY
|
|
| Applicant Contact |
WYNNE, P.E. |
| Correspondent |
| Matrix Medica, Inc. |
| 145 Mid County Dr. |
|
Orchard Park,
NY
|
|
| Correspondent Contact |
WYNNE, P.E. |
| Regulation Number | 868.5160 |
| Classification Product Code |
|
| Date Received | 11/21/1988 |
| Decision Date | 02/09/1989 |
| 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
|
|
|