BEDSIDE BUTLER

System, Environmental Control, Powered

TRAC MEDICAL, INC.

The following data is part of a premarket notification filed by Trac Medical, Inc. with the FDA for Bedside Butler.

Pre-market Notification Details

Device IDK944345
510k NumberK944345
Device Name:BEDSIDE BUTLER
ClassificationSystem, Environmental Control, Powered
Applicant TRAC MEDICAL, INC. 4106 WAKE FOREST RD. Raliegh,  NC  27609
ContactTerry N Williams
CorrespondentTerry N Williams
TRAC MEDICAL, INC. 4106 WAKE FOREST RD. Raliegh,  NC  27609
Product CodeIQA  
CFR Regulation Number890.3725 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-09-06
Decision Date1994-10-17

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