ENDECO ACOUSTIC OTOSCOPE— 510(k) K830139

Substantially Equivalent

Endeco Medical, Inc.

FDA 510(k) clearance K830139 for ENDECO ACOUSTIC OTOSCOPE, Substantially Equivalent on 1983-03-09. 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: 1983-01-13
Decision date: 1983-03-09
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.