AccuContour— 510(k) K191928

Substantially Equivalent

Xiamen Manteia Technology , Ltd.

FDA 510(k) clearance K191928 for AccuContour, Substantially Equivalent on 2020-02-28. Applicant: Xiamen Manteia Technology , Ltd.. Device class: 2.

Clearance details

Applicant
Xiamen Manteia Technology , Ltd.
Product code
Code QKB
Device class
Class 2
Regulation
21 CFR 892.2050
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Xiamen, CN
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