IRIS-XP— 510(k) K212412

Substantially Equivalent

Medicore Co., Ltd.

FDA 510(k) clearance K212412 for IRIS-XP, Substantially Equivalent on 2021-09-13. Applicant: Medicore Co., Ltd.. Device class: 1.

Clearance details

Applicant: Medicore Co., Ltd.
Product code: Code LHQ
Device class: Class 1
Regulation: 21 CFR 884.2980
Advisory panel: Obstetrics/Gynecology
Date received: 2021-08-03
Decision date: 2021-09-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seongnam-Si, KR

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.