The following data is part of a premarket notification filed by Instromedix, Inc. with the FDA for Tape-a-trace.
| Device ID | K791892 |
| 510k Number | K791892 |
| Device Name: | TAPE-A-TRACE |
| Classification | Densitometer |
| Applicant | INSTROMEDIX, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DXM |
| CFR Regulation Number | 870.1450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-09-25 |
| Decision Date | 1979-11-05 |