The following data is part of a premarket notification filed by Chison Medical Imaging Co., Ltd. with the FDA for Chison 600m With C60 Convex Probe, L700 Linear Probe.
| Device ID | K050167 |
| 510k Number | K050167 |
| Device Name: | CHISON 600M WITH C60 CONVEX PROBE, L700 LINEAR PROBE |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | CHISON MEDICAL IMAGING CO., LTD. NO. 8, XIANG NAN ROAD SHUO FANG, NEW DISTRICT Wuxi, CN 214142 |
| Contact | Mo Ruoli |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2005-01-26 |
| Decision Date | 2005-02-08 |