510(k) K072736 ยท ETN Stimulator, Nerve
RHYTHMLINK INTERNATIONAL MONOPOLAR STIMULATING INSTRUMENT
| Applicant | Rhythmlink International, LLC, Columbia SC, US |
| Decision | Substantially Equivalent, Jan 22, 2008 |
| Received | Sep 27, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K072736
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 2, 2015 | Spine Wave, Inc. Spine Wave Access Kit, Catalog Number 10-1530
Package contents: RLSP494-Rhythmlink Monopolar Stimulating Probe and 10-1525 Disposable Dilator Set.
Product Usage:
The Spine Wave Access Kit is comprise Terminated |
ETN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.