HDR Sensor- HDR361 (Size 1), HDR Sensor- HDR461 (Size 2)
K-Number: K221008 · 2022-06-22
Decision Date2022-06-22
Product CodeMUH
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
HDR Sensor- HDR361 (Size 1), HDR Sensor- HDR461 (Size 2) is a medical device manufactured by Shanghai Handy Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2022-06-22 under approval 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. It is manufactured by Shanghai Handy Medical Equipment Co., Ltd.. The 510(k) number is K221008.
When was HDR Sensor- HDR361 (Size 1), HDR Sensor- HDR461 (Size 2) approved by the FDA?
HDR Sensor- HDR361 (Size 1), HDR Sensor- HDR461 (Size 2) received FDA 510(k) clearance on 2022-06-22, under approval number K221008.
What company makes HDR Sensor- HDR361 (Size 1), HDR Sensor- HDR461 (Size 2)?
HDR Sensor- HDR361 (Size 1), HDR Sensor- HDR461 (Size 2) is manufactured by Shanghai Handy Medical Equipment Co., Ltd..
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)
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.