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 |