TINNITUS MASKER— 510(k) K781798

Substantially Equivalent

Starkey Laboratories, Inc.

FDA 510(k) clearance K781798 for TINNITUS MASKER, Substantially Equivalent on 1978-11-03. Applicant: Starkey Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Starkey Laboratories, Inc.
Product code: Code KLW
Device class: Class 2
Regulation: 21 CFR 874.3400
Advisory panel: Ear, Nose, Throat
Date received: 1978-10-23
Decision date: 1978-11-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.