510(k) K082392 ยท FEB Accessories, Cleaning, For Endoscope
EVOTECH ENDOSCOPE CLEANER AND REPROCESSOR
| Applicant | Advanced Sterilization Products, Irvin CA, US |
| Decision | Substantially Equivalent, Nov 13, 2008 |
| Received | Aug 19, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K082392
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 9, 2017 | Advanced Sterilization Products EVOTECH Endoscope Cleaner and Reprocessor System 208V, Product Code: 50004
The EVOTECH ECR Endoscope Cleaner and Reprocessor, a washer/disinfector, is indicated for use with high-level disinfectant C Terminated |
FEB | None listed |
| Apr 18, 2013 | Advanced Sterilization Products EVOTECH Endoscope Cleaner and Reprocessor System, P/N 50004.
Designed to automatically clean and high-level disinfect flexible, submersible video or fiber-optic endoscopes. Terminated |
FEB | None listed |
| Apr 15, 2013 | Advanced Sterilization Products EVOTECH Endoscope Cleaner & Reprocessor System, P/N 50004
Designed to automatically clean and high-level disinfect flexible, submersible video or fiber-optic endoscopes. Terminated |
FEB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.