The following data is part of a premarket notification filed by Honeywell, Inc. with the FDA for Physiological Telemetry Patient Monitoring System.
Device ID | K855125 |
510k Number | K855125 |
Device Name: | PHYSIOLOGICAL TELEMETRY PATIENT MONITORING SYSTEM |
Classification | Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) |
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 | DRT |
CFR Regulation Number | 870.2300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-12-23 |
Decision Date | 1986-03-26 |