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 |
|---|---|---|
| B369MES01001 | K211882 | 000 |
| B369MES01018 | K211882 | 000 |
| B369MES01019 | K211882 | 000 |
| B369MES01020 | K211882 | 000 |
| B369MES01021 | K211882 | 000 |
| B369MES01022 | K211882 | 000 |
| B369MES01023 | K211882 | 000 |
| B369MES01024 | K211882 | 000 |
| B369MES01025 | K211882 | 000 |
| B369MES01026 | K211882 | 000 |
| B369MES01027 | K211882 | 000 |
| B369MES01028 | K211882 | 000 |
| B369MES01029 | K211882 | 000 |
| B369MES01030 | K211882 | 000 |
| B369MES01017 | K211882 | 000 |
| B369MES01016 | K211882 | 000 |
| B369MES01015 | K211882 | 000 |
| B369MES01002 | K211882 | 000 |
| B369MES01003 | K211882 | 000 |
| B369MES01004 | K211882 | 000 |
| B369MES01005 | K211882 | 000 |
| B369MES01006 | K211882 | 000 |
| B369MES01007 | K211882 | 000 |
| B369MES01008 | K211882 | 000 |
| B369MES01009 | K211882 | 000 |
| B369MES01010 | K211882 | 000 |
| B369MES01011 | K211882 | 000 |
| B369MES01012 | K211882 | 000 |
| B369MES01013 | K211882 | 000 |
| B369MES01014 | K211882 | 000 |
| B369MES01031 | K211882 | 000 |
| B369MES01032 | 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 |
| 06945868603441 | K211882 | 000 |
| 06945868603434 | K211882 | 000 |
| B369MES01046 | K211882 | 000 |
| B369MES01033 | K211882 | 000 |
| B369MES01034 | K211882 | 000 |
| B369MES01035 | K211882 | 000 |
| B369MES01036 | K211882 | 000 |
| B369MES01037 | K211882 | 000 |
| B369MES01038 | K211882 | 000 |
| B369MES01039 | K211882 | 000 |
| B369MES01040 | K211882 | 000 |
| B369MES01041 | K211882 | 000 |
| B369MES01042 | K211882 | 000 |
| B369MES01043 | K211882 | 000 |
| B369MES01044 | K211882 | 000 |
| B369MES01045 | K211882 | 000 |
| 06945868605193 | K211882 | 000 |