MICROTRAPPER/MICRODIGITRAPPER, MODIFICATION

Monitor, Breathing Frequency

SYNECTICS-DANTEC

The following data is part of a premarket notification filed by Synectics-dantec with the FDA for Microtrapper/microdigitrapper, Modification.

Pre-market Notification Details

Device IDK905520
510k NumberK905520
Device Name:MICROTRAPPER/MICRODIGITRAPPER, MODIFICATION
ClassificationMonitor, Breathing Frequency
Applicant SYNECTICS-DANTEC 1425 GREENWAY DR. SUITE 600 Irving,  TX  75038
ContactAnna Pettersson
CorrespondentAnna Pettersson
SYNECTICS-DANTEC 1425 GREENWAY DR. SUITE 600 Irving,  TX  75038
Product CodeBZQ  
CFR Regulation Number868.2375 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-12-07
Decision Date1991-04-26

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