SDU 500 DIAGNOSTIC ULTRASOUND INSTRUMENT— 510(k) K910426

Name: FDA 510(k) clearance K910426
Creator: U.S. Food and Drug Administration
Published: 1991-06-06

Substantially Equivalent

Shimadzu Medical Systems

FDA 510(k) clearance K910426 for SDU 500 DIAGNOSTIC ULTRASOUND INSTRUMENT, Substantially Equivalent on 1991-06-06. Applicant: Shimadzu Medical Systems. Device class: 2.

Clearance details

Applicant: Shimadzu Medical Systems
Product code: Code HEM
Device class: Class 2
Regulation: 21 CFR 884.2225
Advisory panel: Obstetrics/Gynecology
Date received: 1991-01-30
Decision date: 1991-06-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gardena, CA, US

Download summary PDF View on FDA.gov ↗

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