PC ECG
FDA 510(k) K160876 · Edan Instruments, Inc.
510(k) numberK160876
Submission
- Device name
- PC ECG
- Applicant
- Edan Instruments, Inc.
Shenzhen, CN - Received
- March 30, 2016
- Decision date
- February 15, 2017
- 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 |
|---|---|---|
| K251508 | Telemetry Monitor (iT30, iT50)MHX · Traditional | 08/06/2026SE |
| K252463 | SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)DPS · Traditional | 07/02/2026SE |
| K251591 | Holter ECG and ABP system (HolterABP)DQK · Traditional | 02/09/2026SE |
| K251268 | Diagnostic Ultrasound System (Nano C5, Nano C5 EXP, Nano L12, and Nano L12 EXP)IYN · Traditional | 12/23/2025SE |
| K241882 | Fetal & Maternal Monitor (F15A, F15A Air)HGM · Traditional | 08/27/2025SE |
| K250179 | Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15)MHX · Traditional | 07/29/2025SE |
| K250214 | Acclarix AX8 Series Diagnostic Ultrasound System (Model: Acclarix AX7, Acclarix AX8…IYN · Traditional | 02/20/2025SE |
| K240320 | Patient Monitor (RespArray)MHX · Traditional | 06/28/2024SE |
| K232786 | Stimulation System (PA series, PR series, S series and Q series)IPF · Traditional | 05/16/2024SE |
| K232962 | Patient Monitor (iX10, iX12, iX15)MHX · Traditional | 04/19/2024SE |
Questions and answers
When was PC ECG cleared by the FDA?
PC ECG (K160876) received a 510(k) decision of Substantially Equivalent on February 15, 2017, 322 days after the submission was received.
What is the product code of K160876?
The FDA product code is DPS – Electrocardiograph, a Class II (moderate risk) device regulated under 21 CFR 870.2340.