ACOUSTIC OTOCOPE RECORDER— 510(k) K850007

Substantially Equivalent

Endeco Medical, Inc.

FDA 510(k) clearance K850007 for ACOUSTIC OTOCOPE RECORDER, Substantially Equivalent on 1985-03-01. Applicant: Endeco Medical, Inc.. Device class: 2.

Clearance details

Applicant: Endeco Medical, Inc.
Product code: Code ETY
Device class: Class 2
Regulation: 21 CFR 874.1090
Advisory panel: Ear, Nose, Throat
Date received: 1985-01-02
Decision date: 1985-03-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Marion, MA, US

Download summary PDF View on FDA.gov ↗

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