Audiotone, Inc.
Phoenix, AZ, US
Audiotone, Inc. appears in FDA device records in Phoenix, AZ. FDA records list 12 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 12
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 12 510(k) clearances for Audiotone, Inc. between 1987 and 1988. The busiest year on record is 1988, with 9. The most recent is 1988, with 9.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1987 | 3 |
| 1988 | 9 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K881738 | AUDIOTONE MODEL TLC SECRET IN-THE-EAR HEARING AID | ESD | Substantially Equivalent | |
| K881737 | AUDIOTONE MODEL AVATAR IN-THE-EAR HEARING AID | ESD | Substantially Equivalent | |
| K881653 | AUDIOTONE MODEL ASP SECRET IN-THE-EAR HEARING AID | ESD | Substantially Equivalent | |
| K881652 | AUDIOTONE MODEL A-61 BEHIND-THE-EAR HEARING AID | ESD | Substantially Equivalent | |
| K880223 | MAGIC EAR MODEL MB BEHIND-THE-EAR HEARING AID | ESD | Substantially Equivalent | |
| K880225 | MAGIC EAR MODEL CI IN-THE-EAR HEARING AID | ESD | Substantially Equivalent | |
| K880224 | MAGIC EAR MODEL MC BEHIND-THE-EAR HEARING AID | ESD | Substantially Equivalent | |
| K874384 | AUDIOTONE MODEL A-90, BEHIND-THE-EAR HEARING AID | ESD | Substantially Equivalent | |
| K874385 | AUDIOTONE MODEL MSP, IN-THE-EAR HEARING AID | ESD | Substantially Equivalent | |
| K874323 | MODEL A-70, BEHIND-THE-EAR HEARING AID | ESD | Substantially Equivalent | |
| K874324 | MODEL A-17, BEHIND-THE-EAR HEARING AID | ESD | Substantially Equivalent | |
| K874325 | MODEL A-72, BEHIND-THE-EAR HEARING AID | ESD | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain