MAICO IN-THE-EAR MODEL RD 201— 510(k) K946253

Name: FDA 510(k) clearance K946253
Creator: U.S. Food and Drug Administration
Published: 1995-01-30

Substantially Equivalent

Maico Hearing Instruments, Inc.

FDA 510(k) clearance K946253 for MAICO IN-THE-EAR MODEL RD 201, Substantially Equivalent on 1995-01-30. Applicant: Maico Hearing Instruments, Inc.. Device class: 1.

Clearance details

Applicant: Maico Hearing Instruments, Inc.
Product code: Code ESD
Device class: Class 1
Regulation: 21 CFR 874.3300
Advisory panel: Ear, Nose, Throat
Date received: 1994-12-23
Decision date: 1995-01-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, US

Download summary PDF View on FDA.gov ↗

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