MINIATURE TEMPERATURE TRAINER MODEL DT-002

Device, Biofeedback

BIO-FEEDBACK SYSTEMS, INC.

The following data is part of a premarket notification filed by Bio-feedback Systems, Inc. with the FDA for Miniature Temperature Trainer Model Dt-002.

Pre-market Notification Details

Device IDK905373
510k NumberK905373
Device Name:MINIATURE TEMPERATURE TRAINER MODEL DT-002
ClassificationDevice, Biofeedback
Applicant BIO-FEEDBACK SYSTEMS, INC. 2736 47TH ST. Boulder,  CO  80301
Product CodeHCC  
CFR Regulation Number882.5050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-11-29
Decision Date1991-04-10

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