MEDDARS/ULTRA IMAGER RESPIRATION MODULE

Monitor, Breathing Frequency

HONEYWELL, INC.

The following data is part of a premarket notification filed by Honeywell, Inc. with the FDA for Meddars/ultra Imager Respiration Module.

Pre-market Notification Details

Device IDK812667
510k NumberK812667
Device Name:MEDDARS/ULTRA IMAGER RESPIRATION MODULE
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 Received1981-09-21
Decision Date1981-10-23

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