Z-Robot Patient Positioning System— 510(k) K182683

Name: FDA 510(k) clearance K182683
Creator: U.S. Food and Drug Administration
Published: 2019-06-27

Substantially Equivalent

Chinan Biomedical Technology, Inc.

FDA 510(k) clearance K182683 for Z-Robot Patient Positioning System, Substantially Equivalent on 2019-06-27. Applicant: Chinan Biomedical Technology, Inc.. Device class: 2.

Clearance details

Applicant: Chinan Biomedical Technology, Inc.
Product code: Code JAI
Device class: Class 2
Regulation: 21 CFR 892.5770
Advisory panel: Radiology
Date received: 2018-09-26
Decision date: 2019-06-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hsinchu County, TW

Download summary PDF View on FDA.gov ↗

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