Cardiac Workstation (5000); Cardiac Workstation (7000)
FDA 510(k) K241556 · Philips Medizin Systeme Böblingen GmbH
510(k) numberK241556
Submission
- Device name
- Cardiac Workstation (5000); Cardiac Workstation (7000)
- Applicant
- Philips Medizin Systeme Böblingen GmbH
Boblingen, DE - Received
- May 31, 2024
- Decision date
- December 17, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DPS – Electrocardiograph
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2340
- Specialty
- Cardiovascular
Other 510(k)s with product code DPS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252463 | SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)DPS · Traditional | Edan Instruments, Inc. | 07/02/2026SE |
| K251670 | MAC 7 Resting ECG Analysis SystemDPS · Traditional | Ge Medical Systems Information Technologies, Inc. | 01/26/2026SE |
| K252361 | AccurECG Analysis System (v2.0)DPS · Traditional | Accurkardia, Inc. | 12/22/2025SE |
| K252474 | Withings BeamO (SCT02)DPS · Traditional | Withings | 11/10/2025SE |
| K250569 | Cardiologs Holter PlatformDPS · Traditional | Philips France Commercial | 08/06/2025SE |
| K243252 | ZBPro DiagnosticDPS · Traditional | Zbeats, Inc. | 07/10/2025SE |
| K243305 | Masimo W1DPS · Traditional | Masimo Corporation | 04/03/2025SE |
| K241217 | CloudHRV System (100-01-001)DPS · Traditional | Inmedix, Inc. | 01/16/2025SE |
| K240229 | Masimo W1DPS · Traditional | Masimo Corporation | 08/08/2024SE |
| K232161 | DeepRhythm PlatformDPS · Traditional | Medicalgorithmics S.A. | 06/20/2024SE |
More from Medicalgorithmics S.A.
| 510(k) | Device | Decision |
|---|---|---|
| K252821 | Reusable Adult SpO2 Clip Sensor (3m) (M1196A); Reusable Adult SpO2 Clip Sensor (0.9m)…DQA · Traditional | 05/29/2026SE |
| K253654 | IntelliVue Measurement Rack 6000 (867317)MSX · Traditional | 03/30/2026SE |
| K251702 | IntelliVue Patient Monitor MX750; IntelliVue Patient Monitor MX850; IntelliVue 4-Slot…MHX · Traditional | 11/10/2025SE |
| K250453 | IntelliVue Patient Monitor 6100 (6100); IntelliVue Patient Monitor 6300 (6300)…MHX · Traditional | 09/02/2025SE |
| K242962 | Telemetry Monitor 5500 Release 4.0 (867232)MHX · Traditional | 05/05/2025SE |
| K241890 | Philips Holter Analysis SystemMLO · Traditional | 03/21/2025SE |
| K243545 | Philips Reusable ECG Lead Sets and Trunk Cables : Model Number,Model Name: 989803170171…DSA · Traditional | 01/17/2025SE |
| K221348 | IntelliVue Patient Monitor MX750 (866471);IntelliVue Patient Monitor MX850 (866470)MHX · Traditional | 02/03/2023SE |
| K211900 | Patient Information Center iXMHX · Traditional | 03/04/2022SE |
Questions and answers
When was Cardiac Workstation (5000); Cardiac Workstation (7000) cleared by the FDA?
Cardiac Workstation (5000); Cardiac Workstation (7000) (K241556) received a 510(k) decision of Substantially Equivalent on December 17, 2024, 200 days after the submission was received.
What is the product code of K241556?
The FDA product code is DPS – Electrocardiograph, a Class II (moderate risk) device regulated under 21 CFR 870.2340.