REXTON HS(HEARING SYSTEM)— 510(k) K791548

Name: FDA 510(k) clearance K791548
Creator: U.S. Food and Drug Administration
Published: 1979-09-28

Substantially Equivalent

Argosy Intl. (Usa), Inc.

FDA 510(k) clearance K791548 for REXTON HS(HEARING SYSTEM), Substantially Equivalent on 1979-09-28. Applicant: Argosy Intl. (Usa), Inc.. Device class: 2.

Clearance details

Applicant: Argosy Intl. (Usa), Inc.
Product code: Code HSD
Device class: Class 2
Regulation: 21 CFR 888.3690
Advisory panel: Orthopedic
Date received: 1979-08-13
Decision date: 1979-09-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K823075 — REXTON1982-11-08
K781094 — HEARING AID, EYEGLASS1978-07-17
K781095 — HEARING AID, BEHIND THE EAR1978-07-17
K781096 — HEARING AID, EYEGLASS, B-121978-07-17
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Adverse events under product code HSD

product code HSD

Injury: 3,425
Malfunction: 531
Total: 3,956

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.