| Device Classification Name |
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
|
| 510(k) Number |
K896030 |
| Device Name |
HEWLETT-PACKARD MODEL M1016A CO2 & M1017A FI02 |
| Applicant |
| Hewlett-Packard Co. |
| 175 Waltham St. |
| P.O.Box 9030 |
|
Waltham,
MA
02254
|
|
| Applicant Contact |
NICHOLAS POLY |
| Correspondent |
| Hewlett-Packard Co. |
| 175 Waltham St. |
| P.O.Box 9030 |
|
Waltham,
MA
02254
|
|
| Correspondent Contact |
NICHOLAS POLY |
| Regulation Number | 868.1400 |
| Classification Product Code |
|
| Date Received | 10/17/1989 |
| Decision Date | 12/22/1989 |
| 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
|
|
|