The following data is part of a premarket notification filed by Metrix Teknika, Inc. with the FDA for Minivisor.
| Device ID | K780035 |
| 510k Number | K780035 |
| Device Name: | MINIVISOR |
| Classification | Monitor, Heart Rate, Fetal, Ultrasonic |
| Applicant | METRIX TEKNIKA, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HEL |
| CFR Regulation Number | 884.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-01-09 |
| Decision Date | 1978-03-06 |