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 |