The following data is part of a premarket notification filed by Beijing Wandong Medical Equipment Co., Ltd. with the FDA for I_open 0.4t.
| Device ID | K090433 |
| 510k Number | K090433 |
| Device Name: | I_OPEN 0.4T |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | BEIJING WANDONG MEDICAL EQUIPMENT CO., LTD. NO. 7, SANJIANFANG NANLI Chao Yang District, Beijing, CN 100024 |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2009-02-19 |
| Decision Date | 2009-03-25 |
| Summary: | summary |