| Device Classification Name |
Transducer, Blood-Pressure, Extravascular
|
| 510(k) Number |
K851888 |
| Device Name |
APM DISPOS. BLOOD PRESSURE TRANSDUCER |
| Applicant |
| Honeywell, Inc. |
| One Campus Dr. |
|
Pleasantville,
NY
10570
|
|
| Applicant Contact |
MARTIN KUTIK |
| Correspondent |
| Honeywell, Inc. |
| One Campus Dr. |
|
Pleasantville,
NY
10570
|
|
| Correspondent Contact |
MARTIN KUTIK |
| Regulation Number | 870.2850 |
| Classification Product Code |
|
| Date Received | 05/01/1985 |
| Decision Date | 08/06/1985 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Cardiovascular
|
| 510k Review Panel |
Cardiovascular
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|