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FDA 510(k)

HDR Sensor- HDR361 (Size 1), HDR Sensor- HDR461 (Size 2)

K-Number: K221008 · 2022-06-22

ApplicantShanghai Handy Medical Equipment Co., Ltd.
Decision Date2022-06-22
Product CodeMUH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

HDR Sensor- HDR361 (Size 1), HDR Sensor- HDR461 (Size 2) is the device name listed in this FDA 510(k) record. The listed applicant is Shanghai Handy Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2022-06-22 under 510(k) number K221008. The device is classified under product code MUH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HDR Sensor- HDR361 (Size 1), HDR Sensor- HDR461 (Size 2)?

HDR Sensor- HDR361 (Size 1), HDR Sensor- HDR461 (Size 2) is a medical device that received FDA 510(k) clearance on 2022-06-22. The listed applicant is Shanghai Handy Medical Equipment Co., Ltd.. The 510(k) number is K221008.

When did HDR Sensor- HDR361 (Size 1), HDR Sensor- HDR461 (Size 2) receive FDA 510(k) clearance?

HDR Sensor- HDR361 (Size 1), HDR Sensor- HDR461 (Size 2) received FDA 510(k) clearance on 2022-06-22, under 510(k) number K221008.

Who is the listed applicant for HDR Sensor- HDR361 (Size 1), HDR Sensor- HDR461 (Size 2)?

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

What is the FDA product code for HDR Sensor- HDR361 (Size 1), HDR Sensor- HDR461 (Size 2)?

The FDA product code for HDR Sensor- HDR361 (Size 1), HDR Sensor- HDR461 (Size 2) is MUH.

Related Devices (Code: MUH)

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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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