AVIVA F22/MAM-CH22 W/OPTIONAL CYTOGUIDE BIOPSY SYS— 510(k) K930282

Name: FDA 510(k) clearance K930282
Creator: U.S. Food and Drug Administration
Published: 1993-08-23

Substantially Equivalent

Elscint, Inc.

FDA 510(k) clearance K930282 for AVIVA F22/MAM-CH22 W/OPTIONAL CYTOGUIDE BIOPSY SYS, Substantially Equivalent on 1993-08-23. Applicant: Elscint, Inc.. Device class: 2.

Clearance details

Applicant: Elscint, Inc.
Product code: Code IZH
Device class: Class 2
Regulation: 21 CFR 892.1710
Advisory panel: Radiology
Date received: 1993-01-21
Decision date: 1993-08-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hackensack, NJ, US

Download summary PDF View on FDA.gov ↗

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