FLOSTAT VASCULAR REPORT GENERATOR (VRG)— 510(k) K973857

Name: FDA 510(k) clearance K973857
Creator: U.S. Food and Drug Administration
Published: 1997-12-29

Substantially Equivalent

Biomedix, Inc.

FDA 510(k) clearance K973857 for FLOSTAT VASCULAR REPORT GENERATOR (VRG), Substantially Equivalent on 1997-12-29. Applicant: Biomedix, Inc.. Device class: 2.

Clearance details

Applicant: Biomedix, Inc.
Product code: Code JAF
Device class: Class 2
Regulation: 21 CFR 892.1540
Advisory panel: Radiology
Date received: 1997-10-09
Decision date: 1997-12-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Camden, NJ, US

Download summary PDF View on FDA.gov ↗

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