EXTENDED OBSTETRICS SOFTWARE COMPUTATION PACKAGE— 510(k) K890637

Name: FDA 510(k) clearance K890637
Creator: U.S. Food and Drug Administration
Published: 1989-06-12

Substantially Equivalent

Elscint, Inc.

FDA 510(k) clearance K890637 for EXTENDED OBSTETRICS SOFTWARE COMPUTATION PACKAGE, Substantially Equivalent on 1989-06-12. Applicant: Elscint, Inc.. Device class: 2.

Clearance details

Applicant: Elscint, Inc.
Product code: Code HEM
Device class: Class 2
Regulation: 21 CFR 884.2225
Advisory panel: Obstetrics/Gynecology
Date received: 1989-02-08
Decision date: 1989-06-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hackensack, NJ, US

Download summary PDF View on FDA.gov ↗

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