NEO NATAL RESPIRATION FUNCTION BLOCK

Monitor, Breathing Frequency

HONEYWELL, INC.

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

Pre-market Notification Details

Device IDK810175
510k NumberK810175
Device Name:NEO NATAL RESPIRATION FUNCTION BLOCK
ClassificationMonitor, Breathing Frequency
Applicant HONEYWELL, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeBZQ  
CFR Regulation Number868.2375 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1981-01-22
Decision Date1981-03-20

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