The following data is part of a premarket notification filed by Medical Dynamics, Inc. with the FDA for True Vision, True Vision Ii.
| Device ID | K974542 |
| 510k Number | K974542 |
| Device Name: | TRUE VISION, TRUE VISION II |
| Classification | Unit, Operative Dental |
| Applicant | MEDICAL DYNAMICS, INC. 99 INVERNESS DR., EAST Englewood, CO 80112 |
| Contact | Edwin L Adair |
| Correspondent | Edwin L Adair MEDICAL DYNAMICS, INC. 99 INVERNESS DR., EAST Englewood, CO 80112 |
| Product Code | EIA |
| CFR Regulation Number | 872.6640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-12-03 |
| Decision Date | 1998-02-17 |