PROBEAT WITH MGCS— 510(k) K060834

Substantially Equivalent

Hitachi , Ltd.

FDA 510(k) clearance K060834 for PROBEAT WITH MGCS, Substantially Equivalent on 2006-04-19. Applicant: Hitachi , Ltd.. Device class: 2.

Clearance details

Applicant: Hitachi , Ltd.
Product code: Code LHN
Device class: Class 2
Regulation: 21 CFR 892.5050
Advisory panel: Radiology
Date received: 2006-03-27
Decision date: 2006-04-19
Decision: Substantially Equivalent
Clearance type: Special
Location: Washington, DC, 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.