SP-1000, SP-2000— 510(k) K202395

Substantially Equivalent

Daesung Maref Co., Ltd.

FDA 510(k) clearance K202395 for SP-1000, SP-2000, Substantially Equivalent on 2021-09-01. Applicant: Daesung Maref Co., Ltd..

Clearance details

Applicant: Daesung Maref Co., Ltd.
Product code: Code IRP
Advisory panel: Physical Medicine
Date received: 2020-08-21
Decision date: 2021-09-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gunpo-Si, KR

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