510(k) K122172 ยท FEB Accessories, Cleaning, For Endoscope
SYSTEM 83 PLUS
| Applicant | Custom Ultrasonics, Ivyland PA, US |
| Decision | Substantially Equivalent, Jan 25, 2013 |
| Received | Jul 23, 2012 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K122172
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 27, 2013 | Custom Ultrasonics, Inc. Custom Ultrasonics System 83 Plus 2 and Plus 9 Endoscope Washer/Disinfector. Terminated |
KOG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.