| Device Classification Name |
Gas-Machine, Anesthesia
|
| 510(k) Number |
K855022 |
| Device Name |
COMPUTERIZED ANESTHESIA RECORDING & INFO NETWORK |
| Applicant |
| Computerized Anesthesia Systems, Inc. |
| 2310 Valley Wood Dr. |
| P.O. Box 13349 |
|
Akron,
OH
44313
|
|
| Applicant Contact |
MARK CRAWFORD |
| Correspondent |
| Computerized Anesthesia Systems, Inc. |
| 2310 Valley Wood Dr. |
| P.O. Box 13349 |
|
Akron,
OH
44313
|
|
| Correspondent Contact |
MARK CRAWFORD |
| Regulation Number | 868.5160 |
| Classification Product Code |
|
| Date Received | 12/16/1985 |
| Decision Date | 02/28/1986 |
| 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
|
|
|