INDEX 2E, INDEX 2F, INDEX 2EF, CARDIOSAT 100E, CARDIOSAT 100F, CARDIOSAT 100EF

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 2e, Index 2f, Index 2ef, Cardiosat 100e, Cardiosat 100f, Cardiosat 100ef.

Pre-market Notification Details

Device IDK971273
510k NumberK971273
Device Name:INDEX 2E, INDEX 2F, INDEX 2EF, CARDIOSAT 100E, CARDIOSAT 100F, CARDIOSAT 100EF
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 Received1997-04-07
Decision Date1997-10-08
Summary:summary

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