510(k) K980306 ยท LNH System, Nuclear Magnetic Resonance Imaging
GYREX 2T PRESTIGE, GYREX PRIMA ITG, GYREX PRIVILEGE, GYREX V-EP
| Applicant | Elscint, Inc., Hackensack NJ, US |
| Decision | Substantially Equivalent, Apr 2, 1998 |
| Received | Jan 27, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K980306
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.