645OB SECTOR/LINEAR ULTRASOUND SCANNER— 510(k) K861931

Name: FDA 510(k) clearance K861931
Creator: U.S. Food and Drug Administration
Published: 1986-07-31

Substantially Equivalent for Some Indications

Ge Medical Systems Information Technologies

FDA 510(k) clearance K861931 for 645OB SECTOR/LINEAR ULTRASOUND SCANNER, Substantially Equivalent for Some Indications on 1986-07-31. 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: 1986-05-20
Decision date: 1986-07-31
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Wallingford, CT, US

Download summary PDF View on FDA.gov ↗

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