BLOOD FLOW ANALYZER— 510(k) K970887

Name: FDA 510(k) clearance K970887
Creator: U.S. Food and Drug Administration
Published: 1997-06-17

Substantially Equivalent

Paradigm Medical Industries, Inc.

FDA 510(k) clearance K970887 for BLOOD FLOW ANALYZER, Substantially Equivalent on 1997-06-17. Applicant: Paradigm Medical Industries, Inc.. Device class: 2.

Clearance details

Applicant: Paradigm Medical Industries, Inc.
Product code: Code HKY
Device class: Class 2
Regulation: 21 CFR 886.1930
Advisory panel: Ophthalmic
Date received: 1997-03-11
Decision date: 1997-06-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Salt Lake City, UT, US

Download summary PDF View on FDA.gov ↗

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