The following data is part of a premarket notification filed by Chison Medical Imaging Co., Ltd. with the FDA for Chison, Model 8300.
| Device ID | K072210 |
| 510k Number | K072210 |
| Device Name: | CHISON, MODEL 8300 |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | CHISON MEDICAL IMAGING CO., LTD. STE 8 ZHONGSHAN MANSION, LANE 999, ZHONGSHAN NO.02 RD (S) Shanghai, CN 200030 |
| Contact | Diana Hong |
| Correspondent | Tamas Borsai TUV RHEINLAND OF NORTH AMERICA, INC. 12 COMMERCE RD. Newton, CT 06470 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2007-08-09 |
| Decision Date | 2007-08-24 |
| Summary: | summary |