PEDRA-1417MC, PEDRA-1417MG, PEDRA-1417FC, PEDRA-1417FG— 510(k) K221144

Name: FDA 510(k) clearance K221144
Creator: U.S. Food and Drug Administration
Published: 2022-05-13

Substantially Equivalent

Radisen Co., Ltd.

FDA 510(k) clearance K221144 for PEDRA-1417MC, PEDRA-1417MG, PEDRA-1417FC, PEDRA-1417FG, Substantially Equivalent on 2022-05-13. Applicant: Radisen Co., Ltd.. Device class: 2.

Clearance details

Applicant: Radisen Co., Ltd.
Product code: Code MQB
Device class: Class 2
Regulation: 21 CFR 892.1680
Advisory panel: Radiology
Date received: 2022-04-20
Decision date: 2022-05-13
Decision: Substantially Equivalent
Clearance type: Special
Location: Seoul, KR

Download summary PDF View on FDA.gov ↗

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