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FDA 510(k)

IRIS-XP

K-Number: K212412 · 2021-09-13

ApplicantMedicore Co., Ltd.
Decision Date2021-09-13
Product CodeLHQ
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

IRIS-XP is a medical device manufactured by Medicore Co., Ltd.. It received FDA 510(k) clearance on 2021-09-13 under approval number K212412. The device is classified under product code LHQ. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IRIS-XP?

IRIS-XP is a medical device that received FDA 510(k) clearance on 2021-09-13. It is manufactured by Medicore Co., Ltd.. The 510(k) number is K212412.

When was IRIS-XP approved by the FDA?

IRIS-XP received FDA 510(k) clearance on 2021-09-13, under approval number K212412.

What company makes IRIS-XP?

IRIS-XP is manufactured by Medicore Co., Ltd..

What is the FDA product code for IRIS-XP?

The FDA product code for IRIS-XP is LHQ.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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