SPEECHLINK 100 TYPE 1053— 510(k) K061104

Substantially Equivalent

Gn Otometrics A/S

FDA 510(k) clearance K061104 for SPEECHLINK 100 TYPE 1053, Substantially Equivalent on 2006-05-03. Applicant: Gn Otometrics A/S.

Clearance details

Applicant: Gn Otometrics A/S
Product code: Code ETW
Advisory panel: Ear, Nose, Throat
Date received: 2006-04-20
Decision date: 2006-05-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taastrup, DK

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