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 the device name listed in this FDA 510(k) record. The listed applicant is Shanghai EA Medical Instruments Co., Ltd.. It received FDA 510(k) clearance on 2023-06-13 under 510(k) 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. The listed applicant is Shanghai EA Medical Instruments Co., Ltd.. The 510(k) number is K223518.

When did iOrtho receive FDA 510(k) clearance?

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

Who is the listed applicant for iOrtho?

The FDA 510(k) record lists Shanghai EA Medical Instruments Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for iOrtho?

The FDA product code for iOrtho is PNN.

Related Devices (Code: PNN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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.