The following data is part of a premarket notification filed by Sonoscape Medical Corp. with the FDA for Hd-500 Video Endoscope System.
| Device ID | K173921 |
| 510k Number | K173921 |
| Device Name: | HD-500 Video Endoscope System |
| Classification | Endoscope, Accessories, Narrow Band Spectrum |
| Applicant | Sonoscape Medical Corp. 4/f, 5/f, 8/f, 9/f & 10/f Yizhe Building, Yuquan Road, Nanshan Shenzhen, CN 518051 |
| 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 | 2017-12-26 |
| Decision Date | 2018-09-05 |