510(k) K090433
K090433 is an FDA 510(k) premarket notification submitted by Beijing Wandong Medical Equipment Co., Ltd. for the device "I_OPEN 0.4T". The FDA issued a decision of Substantially Equivalent on March 25, 2009. The device falls under product code LNH (System, Nuclear Magnetic Resonance Imaging), a Class II device regulated under 21 CFR 892.1000. Beijing Wandong Medical Equipment Co., Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 25, 2009
- Date Received
- February 19, 2009
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- System, Nuclear Magnetic Resonance Imaging
- Device Class
- Class II
- Regulation Number
- 892.1000
- Review Panel
- RA
- Submission Type