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FDA 510(k)

iOrtho

K-Number: K223518 · 2023-06-13

ApplicantShanghai EA Medical Instruments Co., Ltd.
Decision Date2023-06-13
Product CodePNN
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

iOrtho is a medical device manufactured by Shanghai EA Medical Instruments Co., Ltd.. It received FDA 510(k) clearance on 2023-06-13 under approval number K223518. The device is classified under product code PNN. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the iOrtho?

iOrtho is a medical device that received FDA 510(k) clearance on 2023-06-13. It is manufactured by Shanghai EA Medical Instruments Co., Ltd.. The 510(k) number is K223518.

When was iOrtho approved by the FDA?

iOrtho received FDA 510(k) clearance on 2023-06-13, under approval number K223518.

What company makes iOrtho?

iOrtho is manufactured by Shanghai EA Medical Instruments Co., Ltd..

What is the FDA product code for iOrtho?

The FDA product code for iOrtho is PNN.

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Official Source

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

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