The following data is part of a premarket notification filed by Voroba Technologies Assoc. with the FDA for Voroba Technologies, Assoc. Quantum Hearing Aid.
| Device ID | K860170 |
| 510k Number | K860170 |
| Device Name: | VOROBA TECHNOLOGIES, ASSOC. QUANTUM HEARING AID |
| Classification | Hearing Aid, Air Conduction |
| Applicant | VOROBA TECHNOLOGIES ASSOC. 14853 DEVEAU PLACE Minnetonka, MN 55345 |
| Contact | Voroba, Ph.d. |
| Correspondent | Voroba, Ph.d. VOROBA TECHNOLOGIES ASSOC. 14853 DEVEAU PLACE Minnetonka, MN 55345 |
| Product Code | ESD |
| CFR Regulation Number | 874.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-01-17 |
| Decision Date | 1986-04-17 |