Digital Electrocardiographs
FDA 510(k) K131262 · Sonoscape Company Limited
510(k) numberK131262
Submission
- Device name
- Digital Electrocardiographs
- Applicant
- Sonoscape Company Limited
Shanghai, CN - Received
- May 3, 2013
- Decision date
- November 14, 2013
- 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
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| K150045 | S30/S40 Digital Color Doppler Ultraound SystemIYN · Traditional | 04/28/2015SE |
| K142714 | S8 Exp/S9 Pro Portable Digital Color Doppler Ultrasound SystemIYN · Traditional | 01/29/2015SE |
| K142815 | S22 Digital Color Doppler Ultrasound SystemIYN · Traditional | 01/28/2015SE |
| K142710 | S9 Portable Digital Color Doppler Ultrasound SystemIYN · Traditional | 01/05/2015SE |
| K142474 | S12 Digital Color Doppler Ultrasound SystemIYN · Traditional | 12/19/2014SE |
| K132527 | Digital Color Doppler Ultasound SystemIYN · Traditional | 11/14/2013SE |
| K132768 | S8 Exp Portable Digital Color Doppler Ultrasound SystemIYN · Special | 10/04/2013SE |
| K131213 | Digital Color Doppler Ultrasound SystemIYN · Traditional | 06/21/2013SE |
| K130801 | Digital Color Doppler Ultrasound SystemIYN · Traditional | 06/14/2013SE |
| K131088 | Portable Digital Color Doppler Ultrasound SystemIYN · Traditional | 05/24/2013SE |
Questions and answers
When was Digital Electrocardiographs cleared by the FDA?
Digital Electrocardiographs (K131262) received a 510(k) decision of Substantially Equivalent on November 14, 2013, 195 days after the submission was received.
What is the product code of K131262?
The FDA product code is DPS – Electrocardiograph, a Class II (moderate risk) device regulated under 21 CFR 870.2340.