510(k) K112969
K112969 is an FDA 510(k) premarket notification submitted by Niigata Mechatronics Co., Ltd. for the device "AIR-BAG SYSTEM". The FDA issued a decision of Substantially Equivalent on Mar 14, 2012. The device falls under product code LHN (System, Radiation Therapy, Charged-Particle, Medical), a Class II device regulated under 21 CFR 892.5050.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 14, 2012
- Date Received
- Oct 5, 2011
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- System, Radiation Therapy, Charged-Particle, Medical
- Device Class
- Class II
- Regulation Number
- 892.5050
- Review Panel
- RA
- Submission Type
- 510(k)