510(k) K983017 ยท NVE Washer, Cleaner, Automated, Endoscope
MODIFICATION TO SYSTEM 83 PLUS
| Applicant | Custom Ultrasonics, Ivyland PA, US |
| Decision | Substantially Equivalent, Sep 22, 1998 |
| Received | Aug 28, 1998 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K983017
| 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 |
| Mar 7, 2008 | Custom Ultrasonics, Inc. System 83 Plus Washer-Disinfector, Endoscope use, DOS based system, Custom Ultrasonics Inc., Buckingham, PA Terminated |
KOG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.