510(k) K110287 ยท DSA Cable, Transducer And Electrode, Patient, (Including Connector)
PHILIPS ECG LEADWIRE SET
| Applicant | Philips Medical Systems, Andover MA, US |
| Decision | Substantially Equivalent, Feb 15, 2011 |
| Received | Jan 31, 2011 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K110287
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 19, 2019 | Philips North America, LLC Philips 5-Lead Set, Disposable, Bedside, AAMI
Model # 989803173131
Product Usage:
Philips Single-Patient-Use ECG lead sets for bedside monitoring are available in 5-lead configuration Terminated |
DSA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.