Model 456 Electrocardiorecorder Recorder
FDA 510(k) K863652 · Del Mar Avionics
510(k) numberK863652
Submission
- Device name
- Model 456 Electrocardiorecorder Recorder
- Applicant
- Del Mar Avionics
Irvine, CA, US - Received
- September 18, 1986
- Decision date
- December 10, 1986
- 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
| 510(k) | Device | Decision |
|---|---|---|
| K990027 | Omnicorder, Model 464DSH · Abbreviated | 02/09/1999SE |
| K971696 | Sentinel Recorder, Models 471/472DXH · Traditional | 12/30/1997SE |
| K963174 | Holter Digicorder with Pacer Option (Model 483)DSH · Traditional | 03/13/1997SE |
| K950020 | Holter Pacercorder(R)DSH · Traditional | 08/17/1995SE |
| K942653 | Holter SSR Digicorder(Tm)DSH · Traditional | 05/10/1995SE |
| K922221 | Sprint DX, Model 5400 Exercise Stress Test SystemLOS · Traditional | 04/21/1993SE |
| K896862 | Model 263 Spectrascan(Tm) Holter Analysis SystemDSI · Traditional | 04/18/1990SE |
| K895793 | Micropotential Analyzer/Spectrocardiography OptionDSH · Traditional | 02/13/1990SE |
| K894543 | Model 493 SSR-3 Three Channel Solid-State RecorderDSI · Traditional | 02/08/1990SE |
| K891148 | Model 152 Delta Holter ECG Analysis SystemDSI · Traditional | 05/11/1989SE |
Questions and answers
When was Model 456 Electrocardiorecorder Recorder cleared by the FDA?
Model 456 Electrocardiorecorder Recorder (K863652) received a 510(k) decision of Substantially Equivalent on December 10, 1986, 83 days after the submission was received.
What is the product code of K863652?
The FDA product code is DPS – Electrocardiograph, a Class II (moderate risk) device regulated under 21 CFR 870.2340.