510(k) K965044 ยท LNH System, Nuclear Magnetic Resonance Imaging
GYREX 2T PRESTIGE MODEL NO. 100-6321-0107 AND GYREX PRIVILEGE MODEL NO. 100-6326-0102
| Applicant | Elscint, Inc., Hackensack NJ, US |
| Decision | Substantially Equivalent, Jun 16, 1997 |
| Received | Dec 13, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K965044
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.