VOLUME COMPUTATION SOFTWARE PACKAGE— 510(k) K890638

Name: FDA 510(k) clearance K890638
Creator: U.S. Food and Drug Administration
Published: 1989-08-07

Substantially Equivalent

Elscint, Inc.

FDA 510(k) clearance K890638 for VOLUME COMPUTATION SOFTWARE PACKAGE, Substantially Equivalent on 1989-08-07. Applicant: Elscint, Inc.. Device class: 2.

Clearance details

Applicant: Elscint, Inc.
Product code: Code JOP
Device class: Class 2
Regulation: 21 CFR 870.2880
Advisory panel: Cardiovascular
Date received: 1989-02-08
Decision date: 1989-08-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hackensack, NJ, US

Download summary PDF View on FDA.gov ↗

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