Cardiostat 3 Recorder
FDA 510(k) K851044 · Siemens Elema AB
510(k) numberK851044
Submission
- Device name
- Cardiostat 3 Recorder
- Applicant
- Siemens Elema AB
Schaumburg, IL, US - Received
- March 14, 1985
- Decision date
- June 26, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| K241556 | Cardiac Workstation (5000); Cardiac Workstation (7000)DPS · Traditional | Philips Medizin Systeme Böblingen GmbH | 12/17/2024SE |
| K240229 | Masimo W1DPS · Traditional | Masimo Corporation | 08/08/2024SE |
More from Masimo Corporation
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| K010923 | Kion Anaesthesia System, Model 65 03 879 E392EMHX · Abbreviated | 01/23/2002SE |
| K010925 | Servoi Ventilator System, Model 64 87 800 E407ECBK · Abbreviated | 12/18/2001SE |
| K002137 | Cathcor DesktopDQK · Traditional | 10/05/2000SE |
| K001315 | Modification to Kion Anesthesia SystemBSZ · Special | 05/26/2000SE |
| K970839 | Servo Ventilator 300ACBK · Traditional | 10/14/1997ST |
| K960168 | Siemens Servo Screen 390 and Servo Computer Module 990CBK · Traditional | 10/25/1996ST |
| K960010 | Servo Ventilator 300 Computer InterfaceCBK · Traditional | 10/25/1996ST |
| K872278 | Siemens O2-AIR Mixer 965BZR · Traditional | 09/03/1987SE |
| K871354 | Servo Ventilator 900 C/DCBK · Traditional | 07/21/1987SE |
Questions and answers
When was Cardiostat 3 Recorder cleared by the FDA?
Cardiostat 3 Recorder (K851044) received a 510(k) decision of Substantially Equivalent on June 26, 1985, 104 days after the submission was received.
What is the product code of K851044?
The FDA product code is DPS – Electrocardiograph, a Class II (moderate risk) device regulated under 21 CFR 870.2340.