PHYSIOLOGIC RECORDER

Electrocardiograph

HONEYWELL, INC.

The following data is part of a premarket notification filed by Honeywell, Inc. with the FDA for Physiologic Recorder.

Pre-market Notification Details

Device IDK810696
510k NumberK810696
Device Name:PHYSIOLOGIC RECORDER
ClassificationElectrocardiograph
Applicant HONEYWELL, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeDPS  
CFR Regulation Number870.2340 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1981-03-16
Decision Date1981-03-27

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