OB ULTRASOUND LINEAR SCANNER 630— 510(k) K842261

Name: FDA 510(k) clearance K842261
Creator: U.S. Food and Drug Administration
Published: 1984-09-19

Substantially Equivalent

Ge Medical Systems Information Technologies

FDA 510(k) clearance K842261 for OB ULTRASOUND LINEAR SCANNER 630, Substantially Equivalent on 1984-09-19. Applicant: Ge Medical Systems Information Technologies. Device class: 2.

Clearance details

Applicant: Ge Medical Systems Information Technologies
Product code: Code HEM
Device class: Class 2
Regulation: 21 CFR 884.2225
Advisory panel: Obstetrics/Gynecology
Date received: 1984-06-07
Decision date: 1984-09-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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