510(k) K091513 ยท DPS Electrocardiograph
SMART ECG SERIES ELECTROCARDIOGRAPH, MODELS SE-3, SE-300A AND 300B, SE-6, SE-600, SE-12, SE-12 EXPRESS AND SE-1200
| Applicant | Edan Instruments, Inc., Yonkers NY, US |
| Decision | Substantially Equivalent, Jul 24, 2009 |
| Received | May 22, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K091513
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 12, 2011 | Edan Instruments, Inc. ECG Cable Part Number: 01.57.471017 for use with the SE-1 series, SE-3 series and SE-601 series Smart Electrocardiograph
ECG cable is an accessory of the following machines: SE-1 series, SE-3 series Terminated |
DPS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.