510(k) K152189 ยท FEB Accessories, Cleaning, For Endoscope
EVOTECH ECR
| Applicant | Advanced Sterilization Products (Asp), Irvin CA, US |
| Decision | Substantially Equivalent, Jul 20, 2016 |
| Received | Aug 5, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K152189
| 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 |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.