INDEX SPO2 SIMULATOR

Oximeter

BIO-TEK INSTRUMENTS, INC.

The following data is part of a premarket notification filed by Bio-tek Instruments, Inc. with the FDA for Index Spo2 Simulator.

Pre-market Notification Details

Device IDK933519
510k NumberK933519
Device Name:INDEX SPO2 SIMULATOR
ClassificationOximeter
Applicant BIO-TEK INSTRUMENTS, INC. HIGHLAND PARK P.O. BOX 998 Winooski,  VT  05404 -0998
ContactMichael N Sevigny
CorrespondentMichael N Sevigny
BIO-TEK INSTRUMENTS, INC. HIGHLAND PARK P.O. BOX 998 Winooski,  VT  05404 -0998
Product CodeDQA  
CFR Regulation Number870.2700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-07-20
Decision Date1994-09-01

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