ABACUS OB ULTRASOUNG COMPUTER SOFTWARE— 510(k) K951393

Name: FDA 510(k) clearance K951393
Creator: U.S. Food and Drug Administration
Published: 1995-05-01

Substantially Equivalent

Solomon Technology Labs

FDA 510(k) clearance K951393 for ABACUS OB ULTRASOUNG COMPUTER SOFTWARE, Substantially Equivalent on 1995-05-01. Applicant: Solomon Technology Labs. Device class: 2.

Clearance details

Applicant: Solomon Technology Labs
Product code: Code HEM
Device class: Class 2
Regulation: 21 CFR 884.2225
Advisory panel: Obstetrics/Gynecology
Date received: 1995-03-27
Decision date: 1995-05-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chandler, AZ, US

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