TCI COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION)— 510(k) K003558

Name: FDA 510(k) clearance K003558
Creator: U.S. Food and Drug Administration
Published: 2001-04-24

Substantially Equivalent

Siemens Hearing Instruments, Inc.

FDA 510(k) clearance K003558 for TCI COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION), Substantially Equivalent on 2001-04-24. Applicant: Siemens Hearing Instruments, Inc.. Device class: 1.

Clearance details

Applicant: Siemens Hearing Instruments, Inc.
Product code: Code ESD
Device class: Class 1
Regulation: 21 CFR 874.3300
Advisory panel: Ear, Nose, Throat
Date received: 2000-11-17
Decision date: 2001-04-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Piscataway, NJ, US

Download summary PDF View on FDA.gov ↗

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