CONTOUROGRAPH M-500

Device, Sensing, Optical Contour

BIO-TEK INSTRUMENTS, INC.

The following data is part of a premarket notification filed by Bio-tek Instruments, Inc. with the FDA for Contourograph M-500.

Pre-market Notification Details

Device IDK800591
510k NumberK800591
Device Name:CONTOUROGRAPH M-500
ClassificationDevice, Sensing, Optical Contour
Applicant BIO-TEK INSTRUMENTS, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeLDK  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1980-03-17
Decision Date1980-04-02

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