The following data is part of a premarket notification filed by Sonoscape Medical Corp. with the FDA for Hd-550 Video Endoscope System.
| Device ID | K222020 |
| 510k Number | K222020 |
| Device Name: | HD-550 Video Endoscope System |
| Classification | Endoscope, Accessories, Narrow Band Spectrum |
| Applicant | Sonoscape Medical Corp. Room 201 & 202, 12th Building, Shenzhen Software Park Phase II 1 Keji Middle 2nd Road, Yuehai Subdistrict, Nansha Shenzhen, CN 51857 |
| Contact | Toki Wu |
| Correspondent | Toki Wu Sonoscape Medical Corp. Room 201 & 202, 12th Building, Shenzhen Software Park Phase II 1 Keji Middle 2nd Road, Yuehai Subdistrict, Nansha Shenzhen, CN 51857 |
| Product Code | NWB |
| Subsequent Product Code | FDF |
| Subsequent Product Code | FDS |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-07-08 |
| Decision Date | 2022-09-08 |