510(k) K112969 ยท LHN System, Radiation Therapy, Charged-Particle, Medical
AIR-BAG SYSTEM
| Applicant | Niigata Mechatronics Co., Ltd., Niigata-City, JP |
| Decision | Substantially Equivalent, Mar 14, 2012 |
| Received | Oct 5, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K112969
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.