Cardio XP
FDA 510(k) K102767 · Bionet Co., Ltd.
510(k) numberK102767
Submission
- Device name
- Cardio XP
- Applicant
- Bionet Co., Ltd.
Irvine, CA, US - Received
- September 24, 2010
- Decision date
- June 3, 2011
- 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 |
| 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 |
|---|---|---|
| K231160 | Cardio Q50, Cardio Q70DPS · Traditional | 12/15/2023SE |
| K231150 | Cardio P1DPS · Traditional | 11/09/2023SE |
| K220535 | Cardio10DPS · Traditional | 11/15/2022SE |
| K220169 | SonoMe Wireless Probe Type Ultrasound Scanner (Model: 5C, 5CB, H5C, 10L, 14L, 10LB…IYN · Traditional | 10/11/2022SE |
| K130322 | SPM-300BZG · Traditional | 11/15/2013SE |
| K113306 | Cardio 7DPS · Traditional | 07/16/2012SE |
| K090895 | Ekg-Plus II SoftwareLOS · Traditional | 08/26/2009SE |
| K082008 | Bionet BM3PLUS Patient MonitorMWI · Traditional | 12/11/2008SE |
| K043598 | FC 1400 Fetal MonitorHGM · Traditional | 12/16/2005SE |
| K043597 | FC 700 Fetal MonitorHGM · Traditional | 12/16/2005SE |
Questions and answers
When was Cardio XP cleared by the FDA?
Cardio XP (K102767) received a 510(k) decision of Substantially Equivalent on June 3, 2011, 252 days after the submission was received.
What is the product code of K102767?
The FDA product code is DPS – Electrocardiograph, a Class II (moderate risk) device regulated under 21 CFR 870.2340.