FIRST MEDIC PULSE OXIMETRY MODULE

Automated External Defibrillators (non-wearable)

COLORADO MEDTECH, INC.

The following data is part of a premarket notification filed by Colorado Medtech, Inc. with the FDA for First Medic Pulse Oximetry Module.

Pre-market Notification Details

Device IDK955890
510k NumberK955890
Device Name:FIRST MEDIC PULSE OXIMETRY MODULE
ClassificationAutomated External Defibrillators (non-wearable)
Applicant COLORADO MEDTECH, INC. 6175 LONGBOW DR. Boulder,  CO  80301
ContactBonnie J Norman
CorrespondentBonnie J Norman
COLORADO MEDTECH, INC. 6175 LONGBOW DR. Boulder,  CO  80301
Product CodeMKJ  
CFR Regulation Number870.5310 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-12-29
Decision Date1997-07-28

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