IOWA ORAL PERFORMANCE ISNTRUMENT— 510(k) K920091

Name: FDA 510(k) clearance K920091
Creator: U.S. Food and Drug Administration
Published: 1992-05-20

Substantially Equivalent

Breakthrough, Inc.

FDA 510(k) clearance K920091 for IOWA ORAL PERFORMANCE ISNTRUMENT, Substantially Equivalent on 1992-05-20. Applicant: Breakthrough, Inc.. Device class: 1.

Clearance details

Applicant: Breakthrough, Inc.
Product code: Code IKE
Device class: Class 1
Regulation: 21 CFR 890.1615
Advisory panel: Physical Medicine
Date received: 1992-01-08
Decision date: 1992-05-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oakdale, IA, 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.