510(k) K832458 ยท NVE Washer, Cleaner, Automated, Endoscope
AUTOMATIC ENDOSCOPE
| Applicant | American Endoscopy, Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Oct 20, 1983 |
| Received | Jul 26, 1983 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K832458
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 16, 2010 | Advanced Sterilization Products ASP Automatic Endoscope Reprocessor (AER), Product Code: 20300 & 20301
The AER is a machine designed to automatically wash and high-level disinfect flexible, submersible fiberoptic or video endoscopes Terminated |
KOG | None listed |
| Nov 7, 2008 | Advanced Sterilization Products ASP Automatic Endoscope Reprocessor, AER Plus Product Code 20300 and AER with printer Product Code 20301
The AER is a machine designed to automatically wash and high-level disinfect flexible, subme Terminated |
FEB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.