GALIX GBI -3S-LP— 510(k) K992706

Name: FDA 510(k) clearance K992706
Creator: U.S. Food and Drug Administration
Published: 2001-03-15

Substantially Equivalent

Galix Biomedical Instrumentation, Inc.

FDA 510(k) clearance K992706 for GALIX GBI -3S-LP, Substantially Equivalent on 2001-03-15. Applicant: Galix Biomedical Instrumentation, Inc.. Device class: 2.

Clearance details

Applicant: Galix Biomedical Instrumentation, Inc.
Product code: Code MLO
Device class: Class 2
Regulation: 21 CFR 870.2800
Advisory panel: Cardiovascular
Date received: 1999-08-12
Decision date: 2001-03-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami Beach, FL, US

Download summary PDF View on FDA.gov ↗

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