PHYSIOLOGICAL TELEMETRY PATIENT MONITORING SYSTEM

Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm)

HONEYWELL, INC.

The following data is part of a premarket notification filed by Honeywell, Inc. with the FDA for Physiological Telemetry Patient Monitoring System.

Pre-market Notification Details

Device IDK855125
510k NumberK855125
Device Name:PHYSIOLOGICAL TELEMETRY PATIENT MONITORING SYSTEM
ClassificationMonitor, Cardiac (incl. Cardiotachometer & Rate Alarm)
Applicant HONEYWELL, INC. ONE CAMPUS DR. Pleasantville,  NY  10570
ContactMartin Kutik
CorrespondentMartin Kutik
HONEYWELL, INC. ONE CAMPUS DR. Pleasantville,  NY  10570
Product CodeDRT  
CFR Regulation Number870.2300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-12-23
Decision Date1986-03-26

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.