The following data is part of a premarket notification filed by Honeywell, Inc. with the FDA for Patient Monitor Model Rm-300.
| Device ID | K850794 |
| 510k Number | K850794 |
| Device Name: | PATIENT MONITOR MODEL RM-300 |
| Classification | Heat-exchanger, Cardiopulmonary Bypass |
| 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 | DTR |
| CFR Regulation Number | 870.4240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-02-26 |
| Decision Date | 1985-04-18 |