Mini Ridge Filter and auxiliary functions for PROBEAT-V— 510(k) K181676

Name: FDA 510(k) clearance K181676
Creator: U.S. Food and Drug Administration
Published: 2018-08-15

Substantially Equivalent

Hitachi Ltd. Healthcare Hitachi Works

FDA 510(k) clearance K181676 for Mini Ridge Filter and auxiliary functions for PROBEAT-V, Substantially Equivalent on 2018-08-15. Applicant: Hitachi Ltd. Healthcare Hitachi Works. Device class: 2.

Clearance details

Applicant: Hitachi Ltd. Healthcare Hitachi Works
Product code: Code LHN
Device class: Class 2
Regulation: 21 CFR 892.5050
Advisory panel: Radiology
Date received: 2018-06-25
Decision date: 2018-08-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hitachi, JP

Download summary PDF View on FDA.gov ↗

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