FirmLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list Authorized Hearing Systems with 31 510(k) clearances. The most recent is a 510(k) clearance dated Jun 6, 1997: RIONET HB-79P.
| Jun 6, 1997 | RIONET HB-79PK971693 · ESD | 510(k) clearances |
| Feb 26, 1997 | AHS OMEGA SPK970057 · ESD | 510(k) clearances |
| Dec 6, 1996 | AHS OMEGA HFK963878 · ESD | 510(k) clearances |
| Dec 6, 1996 | AHS OMEGA CONCEPTK963877 · ESD | 510(k) clearances |
| Nov 27, 1996 | AHS OMEGA K-AMPK963875 · ESD | 510(k) clearances |
| Nov 26, 1996 | AHS OMEGA AGCK963874 · ESD | 510(k) clearances |
| Nov 26, 1996 | AHS OMEGA PPK963876 · ESD | 510(k) clearances |
| Nov 26, 1996 | AHS DELTA 22 TK963881 · ESD | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
