BABE COMPUTER POGRAM FOR OBSTETRIC ULTRASOUND— 510(k) K942490

Name: FDA 510(k) clearance K942490
Creator: U.S. Food and Drug Administration
Published: 1995-02-15

Substantially Equivalent

Medical Soft, Inc.

FDA 510(k) clearance K942490 for BABE COMPUTER POGRAM FOR OBSTETRIC ULTRASOUND, Substantially Equivalent on 1995-02-15. Applicant: Medical Soft, Inc.. Device class: 2.

Clearance details

Applicant: Medical Soft, Inc.
Product code: Code HEM
Device class: Class 2
Regulation: 21 CFR 884.2225
Advisory panel: Obstetrics/Gynecology
Date received: 1994-05-25
Decision date: 1995-02-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ellicott City, MD, US

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