Disposable ECG Monitoring Electrode #4440 60MM, #4420 40MM
FDA 510(k) K950476 · Nikomed U.S.A., Inc.
510(k) numberK950476
Submission
- Device name
- Disposable ECG Monitoring Electrode #4440 60MM, #4420 40MM
- Applicant
- Nikomed U.S.A., Inc.
Doylestown, PA, US - Received
- February 3, 1995
- Decision date
- September 6, 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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| 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 |
|---|---|---|
| K022909 | Nikomed Trace 1 ECG ElectrodesDRX · Special | 01/09/2003SE |
| K000079 | Nikopad Electrosurgical Grounding Pad, Model 4777MHAM · Special | 02/04/2000SE |
| K950473 | Disposable ECG Monitoring ElectrodeDRX · Traditional | 12/12/1995SE |
| K950475 | Disposable ECG Monitoring Electrode #4530, #4540DRX · Traditional | 11/14/1995SE |
| K950472 | Disposable ECG Monitoring Electrode #4110 45MM, #4140 35MMDRX · Traditional | 11/14/1995SE |
| K950480 | Disposable ECG Monitoring Electrode #4539 28X45MMDRX · Traditional | 11/06/1995SE |
| K950478 | Disposable ECG Monitoring Electrode #4570 38X60MMDRX · Traditional | 11/06/1995SE |
| K950477 | Disposable ECG Monitoring Electrode #4560 38X60MMDRX · Traditional | 11/06/1995SE |
| K950474 | Disposable ECG Monitoring Electrode #4533 32X45MMDRX · Traditional | 11/06/1995SE |
| K950471 | Disposable ECG Monitoring Electrode #4580 32X45MMDRX · Traditional | 11/06/1995SE |
Questions and answers
When was Disposable ECG Monitoring Electrode #4440 60MM, #4420 40MM cleared by the FDA?
Disposable ECG Monitoring Electrode #4440 60MM, #4420 40MM (K950476) received a 510(k) decision of Substantially Equivalent on September 6, 1995, 215 days after the submission was received.
What is the product code of K950476?
The FDA product code is DRX – Electrode, Electrocardiograph, a Class II (moderate risk) device regulated under 21 CFR 870.2360.