PROBEAT-V and accessories— 510(k) K153614

Name: FDA 510(k) clearance K153614
Creator: U.S. Food and Drug Administration
Published: 2016-04-21

Substantially Equivalent

Hitachi, Ltd., Health Care Company

FDA 510(k) clearance K153614 for PROBEAT-V and accessories, Substantially Equivalent on 2016-04-21. 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: 2015-12-17
Decision date: 2016-04-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tokyo, JP

Download summary PDF View on FDA.gov ↗

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K152592 — PROBEAT-V2015-11-02
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K151132 — PROBEAT-V2015-06-01

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