| Device Classification Name |
Display, Cathode-Ray Tube, Medical
|
| 510(k) Number |
K851496 |
| Device Name |
ECG MONITOR MODEL RM102 |
| 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 | 870.2450 |
| Classification Product Code |
|
| Date Received | 04/15/1985 |
| Decision Date | 07/24/1985 |
| 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
|
|
|