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FDA 510(k)

Heart5R-110 Portable X-Ray Machine, Heart3R-110 Portable X-ray Machine

K-Number: K220700 · 2022-05-04

ApplicantYian Medical Technology (Haining) Co., Ltd.
Decision Date2022-05-04
Product CodeIZL
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Heart5R-110 Portable X-Ray Machine, Heart3R-110 Portable X-ray Machine is a medical device manufactured by Yian Medical Technology (Haining) Co., Ltd.. It received FDA 510(k) clearance on 2022-05-04 under approval number K220700. The device is classified under product code IZL. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Heart5R-110 Portable X-Ray Machine, Heart3R-110 Portable X-ray Machine?

Heart5R-110 Portable X-Ray Machine, Heart3R-110 Portable X-ray Machine is a medical device that received FDA 510(k) clearance on 2022-05-04. It is manufactured by Yian Medical Technology (Haining) Co., Ltd.. The 510(k) number is K220700.

When was Heart5R-110 Portable X-Ray Machine, Heart3R-110 Portable X-ray Machine approved by the FDA?

Heart5R-110 Portable X-Ray Machine, Heart3R-110 Portable X-ray Machine received FDA 510(k) clearance on 2022-05-04, under approval number K220700.

What company makes Heart5R-110 Portable X-Ray Machine, Heart3R-110 Portable X-ray Machine?

Heart5R-110 Portable X-Ray Machine, Heart3R-110 Portable X-ray Machine is manufactured by Yian Medical Technology (Haining) Co., Ltd..

What is the FDA product code for Heart5R-110 Portable X-Ray Machine, Heart3R-110 Portable X-ray Machine?

The FDA product code for Heart5R-110 Portable X-Ray Machine, Heart3R-110 Portable X-ray Machine is IZL.

Related Clinical Trials

NCT07568795 Clinical Validation of Portable Electronic Stethoscope for Detecting VHD RECRUITING

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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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