The following data is part of a premarket notification filed by Jedmed Instrument Co. with the FDA for Vestibulariset.
| Device ID | K820775 |
| 510k Number | K820775 |
| Device Name: | VESTIBULARISET |
| Classification | Stimulator, Caloric-water |
| Applicant | JEDMED INSTRUMENT CO. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | ETP |
| CFR Regulation Number | 874.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-03-23 |
| Decision Date | 1982-11-03 |