510(k) K140977 ยท FEB Accessories, Cleaning, For Endoscope
EVOTECH ECR
| Applicant | Advanced Sterilization Products, Irvin CA, US |
| Decision | Substantially Equivalent, Dec 22, 2014 |
| Received | Apr 16, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K140977
| 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 |
| Jun 5, 2015 | Advanced Sterilization Products EVOTECH Endoscope Cleaner and Reprocessing System 208V, P/N 50004.
The ASP EVOTECH ECR Endoscope Cleaner and Reprocessor is a washer/disinfector, which is indicated for use with high-level disinfecta Terminated |
FEB | None listed |
| Jun 5, 2015 | Advanced Sterilization Products EVOTECH Endoscope Cleaner and Reprocessing System 220-230V, P/N 50004-002.
The ASP EVOTECH ECR Endoscope Cleaner and Reprocessor is a washer/disinfector, which is indicated for use with high-level di Terminated |
FEB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.