The following data is part of a premarket notification filed by Honeywell, Inc. with the FDA for Ecg Monitor Model Rm102.
Device ID | K851496 |
510k Number | K851496 |
Device Name: | ECG MONITOR MODEL RM102 |
Classification | Display, Cathode-ray Tube, Medical |
Applicant | HONEYWELL, INC. ONE CAMPUS DR. Pleasantville, NY 10570 |
Contact | Martin Kutik |
Correspondent | Martin Kutik HONEYWELL, INC. ONE CAMPUS DR. Pleasantville, NY 10570 |
Product Code | DXJ |
CFR Regulation Number | 870.2450 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-04-15 |
Decision Date | 1985-07-24 |