The following data is part of a premarket notification filed by Kontron Instruments, Inc. with the FDA for Transducer For Kontrol 5mhz Sigma 20.
| Device ID | K843355 |
| 510k Number | K843355 |
| Device Name: | TRANSDUCER FOR KONTROL 5MHZ SIGMA 20 |
| Classification | Stimulator, Vestibular Acceleration, Therapeutic |
| Applicant | KONTRON INSTRUMENTS, INC. 9 PLYMOUTH ST. Everett, MA 02149 |
| Contact | George Cho |
| Correspondent | George Cho KONTRON INSTRUMENTS, INC. 9 PLYMOUTH ST. Everett, MA 02149 |
| Product Code | MHZ |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-08-27 |
| Decision Date | 1984-12-03 |