The following data is part of a premarket notification filed by Shanghai Handy Medical Equipment Co., Ltd with the FDA for Hdr Sensor- Hdr361 (size 1), Hdr Sensor- Hdr461 (size 2).
| Device ID | K221008 |
| 510k Number | K221008 |
| Device Name: | HDR Sensor- HDR361 (Size 1), HDR Sensor- HDR461 (Size 2) |
| Classification | System, X-ray, Extraoral Source, Digital |
| Applicant | Shanghai Handy Medical Equipment Co., Ltd Floor 2, Building No. 11, Lane177, Fulian Er Road Baoshan District, CN 201906 |
| Contact | Marcia Qiu |
| Correspondent | W. Lee Strong 510K FDA Inc. 100 E Granada Blvd, Suite 219 Ormond Beach, FL 32176 |
| Product Code | MUH |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-04-05 |
| Decision Date | 2022-06-22 |