AUDIOMETER— 510(k) K870337

Substantially Equivalent

Bio-Logic Systems Corp.

FDA 510(k) clearance K870337 for AUDIOMETER, Substantially Equivalent on 1987-04-16. Applicant: Bio-Logic Systems Corp.. Device class: 2.

Clearance details

Applicant: Bio-Logic Systems Corp.
Product code: Code ETW
Device class: Class 2
Regulation: 21 CFR 874.3310
Advisory panel: Ear, Nose, Throat
Date received: 1987-01-28
Decision date: 1987-04-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mudelein, IL, US

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