ADD'L TRANSDUCER FOR USE W/EUB-165 ULTRASOUND— 510(k) K901658

Name: FDA 510(k) clearance K901658
Creator: U.S. Food and Drug Administration
Published: 1990-09-04

Substantially Equivalent

Hitachi Medical Corp. of America

FDA 510(k) clearance K901658 for ADD'L TRANSDUCER FOR USE W/EUB-165 ULTRASOUND, Substantially Equivalent on 1990-09-04. Applicant: Hitachi Medical Corp. of America. Device class: 2.

Clearance details

Applicant: Hitachi Medical Corp. of America
Product code: Code DXK
Device class: Class 2
Regulation: 21 CFR 870.2330
Advisory panel: Cardiovascular
Date received: 1990-04-10
Decision date: 1990-09-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tarrytown, NY, 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.