CRAIGWELL AID FITTING SYSTEM AFS— 510(k) K854125

Name: FDA 510(k) clearance K854125
Creator: U.S. Food and Drug Administration
Published: 1986-01-16

Substantially Equivalent

Craigwell Electronics, Ltd.

FDA 510(k) clearance K854125 for CRAIGWELL AID FITTING SYSTEM AFS, Substantially Equivalent on 1986-01-16. Applicant: Craigwell Electronics, Ltd.. Device class: 2.

Clearance details

Applicant: Craigwell Electronics, Ltd.
Product code: Code EWO
Device class: Class 2
Regulation: 21 CFR 874.1050
Advisory panel: Ear, Nose, Throat
Date received: 1985-10-09
Decision date: 1986-01-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wiltshire Sn2 4bj, GB

Download summary PDF View on FDA.gov ↗

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K854124 — CRAIGWELL AID HA3001986-03-26
K854126 — CRAIGWELL MASTER HEARING AID MHA1986-01-16

Adverse events under product code EWO

product code EWO

Other: 2
Total: 2

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.