Cardiac Workstation (5000); Cardiac Workstation (7000)— 510(k) K241556
Substantially EquivalentPhilips Medizin Systeme Böblingen GmbH
FDA 510(k) clearance K241556 for Cardiac Workstation (5000); Cardiac Workstation (7000), Substantially Equivalent on 2024-12-17. Applicant: Philips Medizin Systeme Böblingen GmbH. Device class: 2.
Clearance details
- Applicant
- Philips Medizin Systeme Böblingen GmbH
- Product code
- Code DPS
- Device class
- Class 2
- Regulation
- 21 CFR 870.2340
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Boblingen, DE
Recent devices under product code DPS
view allMore clearances from Philips Medizin Systeme Böblingen GmbH
view all- K252821 — Reusable Adult SpO2 Clip Sensor (3m) (M1196A); Reusable Adult SpO2 Clip Sensor (0.9m) (M1196T)
- K253654 — IntelliVue Measurement Rack 6000 (867317)
- K251702 — IntelliVue Patient Monitor MX750 +2 more
- K250453 — IntelliVue Patient Monitor 6100 (6100); IntelliVue Patient Monitor 6300 (6300); IntelliVue Patient Monitor 6500 (6500)
- K242962 — Telemetry Monitor 5500 Release 4.0 (867232)
Adverse events under product code DPS
product code DPS- Death
- 7
- Total
- 7
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K241556
K-number listed on FDA's recall record- Z-2955-2026 — Cardiac Workstation 5000. Product Number: 860439.
- Z-2956-2026 — Cardiac Workstation 7000. Product Number: 860441.
- Z-0165-2026 — Cardiac Workstation 5000; Model Number: 860439;
- Z-0166-2026 — Cardiac Workstation 7000; Model Number: 860441;
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K241556.
Data sourced from openFDA. This site is unofficial and independent of the FDA.