BIOMA 3500

Tester, Electrode, Surface, Electrocardiographic

E.B.S., INC.

The following data is part of a premarket notification filed by E.b.s., Inc. with the FDA for Bioma 3500.

Pre-market Notification Details

Device IDK872370
510k NumberK872370
Device Name:BIOMA 3500
ClassificationTester, Electrode, Surface, Electrocardiographic
Applicant E.B.S., INC. 660 ROCHON ST-LAURENT (QUEBEC) Canada,  CA H4l 1t4
ContactSylvain Boucher
CorrespondentSylvain Boucher
E.B.S., INC. 660 ROCHON ST-LAURENT (QUEBEC) Canada,  CA H4l 1t4
Product CodeKRC  
CFR Regulation Number870.2370 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-06-19
Decision Date1987-12-07

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