The following data is part of a premarket notification filed by Medical Instruments Technology, Inc. with the FDA for The Orthoranger Ii Electronic Goniometer.
| Device ID | K884611 |
| 510k Number | K884611 |
| Device Name: | THE ORTHORANGER II ELECTRONIC GONIOMETER |
| Classification | Goniometer, Ac-powered |
| Applicant | MEDICAL INSTRUMENTS TECHNOLOGY, INC. 1199 NORTH FAIRFAX ST. SUITE 601 Alexandria, VA 22314 |
| Contact | Philip M Shapiro |
| Correspondent | Philip M Shapiro MEDICAL INSTRUMENTS TECHNOLOGY, INC. 1199 NORTH FAIRFAX ST. SUITE 601 Alexandria, VA 22314 |
| Product Code | KQX |
| CFR Regulation Number | 888.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-11-04 |
| Decision Date | 1989-01-31 |