ANGIOSCAN SPECTRUM ANALYZER— 510(k) K812184

Name: FDA 510(k) clearance K812184
Creator: U.S. Food and Drug Administration
Published: 1981-09-09

Substantially Equivalent

Unigon Industries, Inc.

FDA 510(k) clearance K812184 for ANGIOSCAN SPECTRUM ANALYZER, Substantially Equivalent on 1981-09-09. Applicant: Unigon Industries, Inc.. Device class: 2.

Clearance details

Applicant: Unigon Industries, Inc.
Product code: Code DXK
Device class: Class 2
Regulation: 21 CFR 870.2330
Advisory panel: Cardiovascular
Date received: 1981-08-03
Decision date: 1981-09-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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