DAHLBERG MODEL GF MICROPROCESSOR AUDIOMETER— 510(k) K854835

Name: FDA 510(k) clearance K854835
Creator: U.S. Food and Drug Administration
Published: 1986-03-04

Substantially Equivalent

Miracle-Ear/Dahlberg, Inc.

FDA 510(k) clearance K854835 for DAHLBERG MODEL GF MICROPROCESSOR AUDIOMETER, Substantially Equivalent on 1986-03-04. Applicant: Miracle-Ear/Dahlberg, Inc.. Device class: 2.

Clearance details

Applicant: Miracle-Ear/Dahlberg, Inc.
Product code: Code EWO
Device class: Class 2
Regulation: 21 CFR 874.1050
Advisory panel: Ear, Nose, Throat
Date received: 1985-12-03
Decision date: 1986-03-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Golden Valley, MN, US

Download summary PDF View on FDA.gov ↗

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More clearances from Miracle-Ear/Dahlberg, Inc.

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K942893 — MIRACLE-EAR MODEL PGF + REMOTE1994-08-17
K942894 — MIRACLE-EAR MODEL PGC1994-08-17
K942895 — MIRACLE EAR MODEL PGM1994-08-17
K941859 — MIRACLE-EAR EAR IMPRESSION MATERIAL1994-07-25
K862099 — DAHLBERG MODEL EE BEHIND-THE-EAR HEARING AID1986-06-23

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.