510(k) K241556 · DPS Electrocardiograph
Cardiac Workstation (5000); Cardiac Workstation (7000)
| Applicant | Philips Medizin Systeme Böblingen GmbH, Boblingen, DE |
| Decision | Substantially Equivalent, Dec 17, 2024 |
| Received | May 31, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K241556
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 14, 2026 | Philips North America Llc Cardiac Workstation 5000. Product Number: 860439. Open, Classified |
DPS | None listed |
| Aug 14, 2026 | Philips North America Llc Cardiac Workstation 7000. Product Number: 860441. Open, Classified |
DPS | None listed |
| Oct 16, 2025 | Philips North America Cardiac Workstation 5000;
Model Number: 860439; Open, Classified |
DPS | None listed |
| Oct 16, 2025 | Philips North America Cardiac Workstation 7000;
Model Number: 860441; Open, Classified |
DPS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.