FDA 510(k) Premarket Notification K221008: HDR Sensor- HDR361 (Size 1), HDR Sensor- HDR461 (Size 2)

Submission Details & Decision

Normalized public record details for 510(k) notification K221008.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K221008

Applicant / Sponsor

Shanghai Handy Medical Equipment Co., Ltd.

Device Name

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

Product Code

MUH

Decision Date

2022-06-22

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Dental (DE)

Clearance Type

Traditional

Third Party Flag

Date Received

2022-04-05

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