510(k) K021288 ยท LHC Warmer, Irrigation Solution
ORS-1000LD
| Applicant | O.R. Solutions, Inc., Chantilly VA, US |
| Decision | Substantially Equivalent, Jun 27, 2002 |
| Received | Apr 23, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K021288
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 18, 2015 | Ecolab Inc Microtek Medical, Inc. ORS Fluid Warming and Slush Drapes, Model #'s ORS-100, ORS-110, ORS-130, ORS-300, ORS-301, ORS-320, ORS-321, ORS-325, ORS-330, ORS-331
and ORS-2200.
The ORS Fluid Warming and Terminated |
LHC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.