The following data is part of a premarket notification filed by Arthrotek, Inc. with the FDA for Arthrophonometer.
| Device ID | K862286 |
| 510k Number | K862286 |
| Device Name: | ARTHROPHONOMETER |
| Classification | Device, Dental Sonography, For Monitoring Jaw Sounds |
| Applicant | ARTHROTEK, INC. 30 SHERMAN ST. West Hartford, CT 06110 |
| Contact | John S Hall |
| Correspondent | John S Hall ARTHROTEK, INC. 30 SHERMAN ST. West Hartford, CT 06110 |
| Product Code | NFQ |
| CFR Regulation Number | 872.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-06-16 |
| Decision Date | 1987-01-07 |