ClariSIGMAM— 510(k) K203785

Substantially Equivalent

Claripi, Inc.

FDA 510(k) clearance K203785 for ClariSIGMAM, Substantially Equivalent on 2021-09-10. Applicant: Claripi, Inc.. Device class: 2.

Clearance details

Applicant: Claripi, Inc.
Product code: Code QIH
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2020-12-28
Decision date: 2021-09-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seoul, KR

Download summary PDF View on FDA.gov ↗

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