CRAIGWELL MASTER HEARING AID MHA— 510(k) K854126

Name: FDA 510(k) clearance K854126
Creator: U.S. Food and Drug Administration
Published: 1986-01-16

Substantially Equivalent

Craigwell Electronics, Ltd.

FDA 510(k) clearance K854126 for CRAIGWELL MASTER HEARING AID MHA, Substantially Equivalent on 1986-01-16. Applicant: Craigwell Electronics, Ltd.. Device class: 2.

Clearance details

Applicant: Craigwell Electronics, Ltd.
Product code: Code KHL
Device class: Class 2
Regulation: 21 CFR 874.3330
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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Data sourced from openFDA. This site is unofficial and independent of the FDA.