AUTO-TYMPANIGRAPH (TA-5A)— 510(k) K811509

Name: FDA 510(k) clearance K811509
Creator: U.S. Food and Drug Administration
Published: 1981-06-16

Substantially Equivalent

Teledyne Avionics Div. of Teledyne

FDA 510(k) clearance K811509 for AUTO-TYMPANIGRAPH (TA-5A), Substantially Equivalent on 1981-06-16. Applicant: Teledyne Avionics Div. of Teledyne. Device class: 2.

Clearance details

Applicant: Teledyne Avionics Div. of Teledyne
Product code: Code ETY
Device class: Class 2
Regulation: 21 CFR 874.1090
Advisory panel: Ear, Nose, Throat
Date received: 1981-05-27
Decision date: 1981-06-16
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.