RESPIRATION FUNCTION BLOCKS

Monitor, Breathing Frequency

HONEYWELL, INC.

The following data is part of a premarket notification filed by Honeywell, Inc. with the FDA for Respiration Function Blocks.

Pre-market Notification Details

Device IDK810174
510k NumberK810174
Device Name:RESPIRATION FUNCTION BLOCKS
ClassificationMonitor, Breathing Frequency
Applicant HONEYWELL, INC. 4221 Richmond Rd., N.W. Walker,  MI  49534
Product CodeBZQ  
CFR Regulation Number868.2375 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1981-01-22
Decision Date1981-03-17

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