ECG Electrode
FDA 510(k) K944260 · Msb , Ltd.
510(k) numberK944260
Submission
- Device name
- ECG Electrode
- Applicant
- Msb , Ltd.
Marlborough, Wiltshire, GB - Received
- August 30, 1994
- Decision date
- July 7, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- DRX – Electrode, Electrocardiograph
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2360
- Specialty
- Cardiovascular
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|---|---|---|---|
| K171244 | PhysiotraceDRX · Traditional | Nimbleheart, Inc. | 08/23/2017SE |
| K140096 | Hmicro Wired C-Patch Electrode, Trade Name Subject to ChangeDRX · Traditional | Hmicro, Inc. | 07/24/2014SE |
| K123658 | Biomodule 3-M1DRX · Traditional | Zephyr Technology Corporation | 04/24/2013SE |
| K101576 | Centerridge Diagnostic ECG Electrode, Centerridge Monitoring ECG ElectrodesDRX · Traditional | Team Innovations, Inc. | 07/22/2010SE |
| K101685 | Ip-SetDRX · Traditional | Integral Process Sas | 07/01/2010SE |
| K100129 | Ambu Blue Sensor Neo, Ambu Blue Sensor Neo XDRX · Abbreviated | Ambu A/S | 06/11/2010SE |
| K093327 | Intco Tab ElectrodeDRX · Abbreviated | Shanghai Intco Electrode Manufacturing Co., Ltd. | 05/10/2010SE |
| K100315 | 12 Lead GloveDRX · Special | I Needmd, Inc. | 04/23/2010SE |
| K092744 | Neonatal ECG Electrode, M203KENDRX · Traditional | R & D Medical Products, Inc. | 12/10/2009SE |
| K092389 | Disposal ECG Electrodes, Model EasyrodeDRX · Traditional | Suzuken Co., Ltd. | 10/13/2009SE |
More from Suzuken Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K980229 | MSB TENS Electrodes (Disposable)GXY · Traditional | 02/27/1998SE |
| K944497 | Unilect, Monitab and Biotrace-HrDRX · Traditional | 05/17/1996SE |
| K944496 | Biotrace-N, NS, 410 and RTDRX · Traditional | 05/16/1996SE |
| K955261 | Neutralect Adult Standard, Return (Rem) & Paediatric Electrosurgery Plate (Modification)GEI · Traditional | 01/30/1996SE |
| K950587 | EcotabsDRX · Traditional | 10/16/1995SE |
| K944817 | Neutralect Adult Standard, Return (Rem), Paediatric Standard, Return (Rem)GEI · Traditional | 11/09/1994SE |
Questions and answers
When was ECG Electrode cleared by the FDA?
ECG Electrode (K944260) received a 510(k) decision of Substantially Equivalent on July 7, 1995, 311 days after the submission was received.
What is the product code of K944260?
The FDA product code is DRX – Electrode, Electrocardiograph, a Class II (moderate risk) device regulated under 21 CFR 870.2360.