Extended Range Shifter for PROBEAT-V— 510(k) K152207

Name: FDA 510(k) clearance K152207
Creator: U.S. Food and Drug Administration
Published: 2015-10-02

Substantially Equivalent

Hitachi, Ltd., Health Care Company

FDA 510(k) clearance K152207 for Extended Range Shifter for PROBEAT-V, Substantially Equivalent on 2015-10-02. Applicant: Hitachi, Ltd., Health Care Company. Device class: 2.

Clearance details

Applicant: Hitachi, Ltd., Health Care Company
Product code: Code LHN
Device class: Class 2
Regulation: 21 CFR 892.5050
Advisory panel: Radiology
Date received: 2015-08-06
Decision date: 2015-10-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tokyo, JP

Download summary PDF View on FDA.gov ↗

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