CUSTOM TCI-COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION)— 510(k) K011366

Name: FDA 510(k) clearance K011366
Creator: U.S. Food and Drug Administration
Published: 2001-06-01

Substantially Equivalent

Siemens Hearing Instruments, Inc.

FDA 510(k) clearance K011366 for CUSTOM TCI-COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION), Substantially Equivalent on 2001-06-01. Applicant: Siemens Hearing Instruments, Inc.. Device class: 2.

Clearance details

Applicant: Siemens Hearing Instruments, Inc.
Product code: Code KLW
Device class: Class 2
Regulation: 21 CFR 874.3400
Advisory panel: Ear, Nose, Throat
Date received: 2001-05-04
Decision date: 2001-06-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Piscataway, NJ, US

Download summary PDF View on FDA.gov ↗

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