510(k) K043354 ยท DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
MODULAR TELEMETRY SYSTEM FOR THE VISION TELEPAK, MODEL 20701
| Applicant | Invivo Research, Inc., Orlando FL, US |
| Decision | Substantially Equivalent, Jan 10, 2005 |
| Received | Dec 6, 2004 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K043354
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.