The following data is part of a premarket notification filed by Bio-tek Instruments, Inc. with the FDA for Contourograph M-500.
Device ID | K800591 |
510k Number | K800591 |
Device Name: | CONTOUROGRAPH M-500 |
Classification | Device, Sensing, Optical Contour |
Applicant | BIO-TEK INSTRUMENTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | LDK |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-03-17 |
Decision Date | 1980-04-02 |