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 | K211882 |
| 510k Number | K211882 |
| Device Name: | HD-550 Video Endoscope System |
| Classification | Endoscope, Accessories, Narrow Band Spectrum |
| Applicant | Sonoscape Medical Corp Room 201&2, 12th Building, Shenzhen Software Park Phase II, 1 Keji Middle 2nd Road, Yuehai Subdistrict, Nanshan District Shenzhen, CN 518057 |
| Contact | Toki Wu |
| Correspondent | Diana Hong Mid-Link Consulting Co.,Ltd P.O.BOX 120-119 Shanghai, CN 200120 |
| 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 | 2021-06-21 |
| Decision Date | 2022-04-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06945868605193 | K211882 | 000 |
| 06945868603441 | K211882 | 000 |
| 06945868603458 | K211882 | 000 |
| 06945868603465 | K211882 | 000 |
| 06945868603540 | K211882 | 000 |
| 06945868603557 | K211882 | 000 |
| 06945868603564 | K211882 | 000 |
| 06945868603571 | K211882 | 000 |
| 06945868603588 | K211882 | 000 |
| 06945868603601 | K211882 | 000 |
| 06945868603618 | K211882 | 000 |
| 06945868603854 | K211882 | 000 |
| 06945868603861 | K211882 | 000 |
| 06945868605155 | K211882 | 000 |
| 06945868605186 | K211882 | 000 |
| 06945868603434 | K211882 | 000 |