SONOACE 88 PORTABLE ULTRASOUND SCANNER— 510(k) K900505

Name: FDA 510(k) clearance K900505
Creator: U.S. Food and Drug Administration
Published: 1990-08-10

Substantially Equivalent

Medison Co., Ltd.

FDA 510(k) clearance K900505 for SONOACE 88 PORTABLE ULTRASOUND SCANNER, Substantially Equivalent on 1990-08-10. Applicant: Medison Co., Ltd.. Device class: 2.

Clearance details

Applicant: Medison Co., Ltd.
Product code: Code HEM
Device class: Class 2
Regulation: 21 CFR 884.2225
Advisory panel: Obstetrics/Gynecology
Date received: 1990-02-02
Decision date: 1990-08-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Media, PA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.