510(k) K010057 ยท LNH System, Nuclear Magnetic Resonance Imaging
MODIFICATION TO ARTOSCAN M
| Applicant | Biosound Esaote, Inc., Indianapolis IN, US |
| Decision | Substantially Equivalent, Feb 2, 2001 |
| Received | Jan 8, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K010057
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.