Authorized Hearing Systems, Inc.
Levittown, PA, US
Authorized Hearing Systems, Inc. appears in FDA device records in Levittown, PA. FDA records list 31 510(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
- 31
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 31 510(k) clearances for Authorized Hearing Systems, Inc. between 1986 and 1997. The busiest year on record is 1996, with 12. The most recent is 1997, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1986 | 1 |
| 1992 | 8 |
| 1993 | 3 |
| 1994 | 4 |
| 1995 | 1 |
| 1996 | 12 |
| 1997 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K971693 | RIONET HB-79P | ESD | Substantially Equivalent | |
| K970057 | AHS OMEGA SP | ESD | Substantially Equivalent | |
| K963878 | AHS OMEGA HF | ESD | Substantially Equivalent | |
| K963877 | AHS OMEGA CONCEPT | ESD | Substantially Equivalent | |
| K963875 | AHS OMEGA K-AMP | ESD | Substantially Equivalent | |
| K963881 | AHS DELTA 22 T | ESD | Substantially Equivalent | |
| K963879 | AHS DELTA 22 | ESD | Substantially Equivalent | |
| K963876 | AHS OMEGA PP | ESD | Substantially Equivalent | |
| K963874 | AHS OMEGA AGC | ESD | Substantially Equivalent | |
| K963873 | AHS OMEGA DEQ | ESD | Substantially Equivalent | |
| K963154 | RIONET HB-54AS | ESD | Substantially Equivalent | |
| K963153 | RIONET HB-55S | ESD | Substantially Equivalent | |
| K963152 | RIONET HB-55AS | ESD | Substantially Equivalent | |
| K961907 | RIONET HEARING AID HB53-K | ESD | Substantially Equivalent | |
| K951677 | RIONET HEARING AID HM-02 | ESD | Substantially Equivalent | |
| K944161 | IMAGE | ESD | Substantially Equivalent | |
| K941140 | RIONET HEARING AID HB-37T | ESD | Substantially Equivalent | |
| K941021 | RIONET HEARING AID HB-54 | ESD | Substantially Equivalent | |
| K936122 | RIONET HEARING AID HB-53CI | ESD | Substantially Equivalent | |
| K934480 | RIONET HEARING AID HA-73 | ESD | Substantially Equivalent | |
| K934479 | RIONET HEARING AID HA-72 | ESD | Substantially Equivalent | |
| K930721 | RIONET HEARING AID HB-53S | ESD | Substantially Equivalent | |
| K923801 | RIONET HB75-AL BTE AID | ESD | Substantially Equivalent | |
| K921829 | RIONET HEARING AID HB-52S | ESD | Substantially Equivalent | |
| K921830 | RIONET HEARING AID HB-52T | ESD | Substantially Equivalent | |
| K920897 | RIONET HEARING AID - HB 52DU | ESD | Substantially Equivalent | |
| K920522 | RIONET HEARING AID HB-23M | ESD | Substantially Equivalent | |
| K920521 | RIONET HEARING AID HB-23T | ESD | Substantially Equivalent | |
| K920486 | RIONET HEARING AID HB-53P | ESD | Substantially Equivalent | |
| K915875 | RIONET HEARING AID HB-71K (K-AMP) | ESD | Substantially Equivalent | |
| K862169 | ALPHA ALL-IN-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
