INTERACOUSTICS MODEL MT 10, HANDHELD IMPEDANCE AUDIOMETER— 510(k) K983832

Name: FDA 510(k) clearance K983832
Creator: U.S. Food and Drug Administration
Published: 1999-01-25

Substantially Equivalent

Idem (Int'L Dist. of Electronics For Medicine)

FDA 510(k) clearance K983832 for INTERACOUSTICS MODEL MT 10, HANDHELD IMPEDANCE AUDIOMETER, Substantially Equivalent on 1999-01-25. Applicant: Idem (Int'L Dist. of Electronics For Medicine). Device class: 2.

Clearance details

Applicant: Idem (Int'L Dist. of Electronics For Medicine)
Product code: Code ETY
Device class: Class 2
Regulation: 21 CFR 874.1090
Advisory panel: Ear, Nose, Throat
Date received: 1998-10-30
Decision date: 1999-01-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Benicia, CA, 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.