The following data is part of a premarket notification filed by Magnatone Hearing Aid Corp. Dba Persona Medical with the FDA for Evok 900 Series Hearing Aid/tinnitus Masker Option Device.
| Device ID | K093715 |
| 510k Number | K093715 |
| Device Name: | EVOK 900 SERIES HEARING AID/TINNITUS MASKER OPTION DEVICE |
| Classification | Masker, Tinnitus |
| Applicant | MAGNATONE HEARING AID CORP. DBA PERSONA MEDICAL 170 N. CYPRESS WAY Casselberry, FL 32707 |
| Contact | Don Campbell |
| Correspondent | Don Campbell MAGNATONE HEARING AID CORP. DBA PERSONA MEDICAL 170 N. CYPRESS WAY Casselberry, FL 32707 |
| Product Code | KLW |
| CFR Regulation Number | 874.3400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-12-01 |
| Decision Date | 2010-12-22 |
| Summary: | summary |