Kenl-Ecg
FDA 510(k) K811950 · Suzuken Co., Ltd.
510(k) numberK811950
Submission
- Device name
- Kenl-Ecg
- Applicant
- Suzuken Co., Ltd.
Mchenry, IL, US - Received
- July 7, 1981
- Decision date
- August 13, 1981
- 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 |
|---|---|---|
| K172068 | Kenz Cardico1211DPS · Traditional | 06/01/2018SE |
| K101024 | Kenz CARDY302 MaxMWJ · Traditional | 01/06/2011SE |
| K092389 | Disposal ECG Electrodes, Model EasyrodeDRX · Traditional | 10/13/2009SE |
| K001896 | Kenz ECG 108 Single Channel Digital Electrocardiographs; Kenz ECG 110 Single Channel…DPS · Traditional | 01/08/2001SE |
| K870443 | Kenz-Cardico 1201LOS · Traditional | 07/01/1987SE |
| K862544 | KENZ-ECG-102 Single Channel ElectrocardiographDPS · Traditional | 08/06/1986SE |
| K843731 | Kenz 80Z Mark IIDSI · Traditional | 07/11/1985SE |
| K822968 | Electrocardiograph InterpreterDSI · Traditional | 12/15/1982SE |
| K820854 | KENZ-45MDXN · Traditional | 06/01/1982SE |
| K820991 | Kenz-Gelect Gel PadGYB · Traditional | 04/26/1982SE |
Questions and answers
When was Kenl-Ecg cleared by the FDA?
Kenl-Ecg (K811950) received a 510(k) decision of Substantially Equivalent on August 13, 1981, 37 days after the submission was received.
What is the product code of K811950?
The FDA product code is DPS – Electrocardiograph, a Class II (moderate risk) device regulated under 21 CFR 870.2340.