510(k) K090367 ยท DPS Electrocardiograph
SE-601 SERIES ELECTROCARDIOGRAPH
| Applicant | Edan Instruments, Inc., Yonkers NY, US |
| Decision | Substantially Equivalent, Jun 3, 2009 |
| Received | Feb 13, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K090367
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 13, 2012 | Del Mar Reynolds Medical, Ltd. Affected device is Model 98400-SL6-AHA, CardioExpress Electrocardiograph. The ECG cable part number is 01.57.471017. The electrocardiograph is only intended to be used in hospitals or healthcare faci Terminated |
DPS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.