PATIENT MONITOR MODEL RM-300

Heat-exchanger, Cardiopulmonary Bypass

HONEYWELL, INC.

The following data is part of a premarket notification filed by Honeywell, Inc. with the FDA for Patient Monitor Model Rm-300.

Pre-market Notification Details

Device IDK850794
510k NumberK850794
Device Name:PATIENT MONITOR MODEL RM-300
ClassificationHeat-exchanger, Cardiopulmonary Bypass
Applicant HONEYWELL, INC. ONE CAMPUS DR. Pleasantville,  NY  10570
ContactMartin Kutik
CorrespondentMartin Kutik
HONEYWELL, INC. ONE CAMPUS DR. Pleasantville,  NY  10570
Product CodeDTR  
CFR Regulation Number870.4240 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-02-26
Decision Date1985-04-18

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