Sensi-Prema Neonatal ECG Electrodes, 40612,40614,40626,40550,40554,40555,440556,40610,40613,40625,40801
FDA 510(k) K003804 · Niko Medical Products
510(k) numberK003804
Submission
- Device name
- Sensi-Prema Neonatal ECG Electrodes, 40612,40614,40626,40550,40554,40555,440556,40610,40613,40625,40801
- Applicant
- Niko Medical Products
Fort Worth, TX, US - Received
- December 8, 2000
- Decision date
- August 30, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DRX – Electrode, Electrocardiograph
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2360
- Specialty
- Cardiovascular
Other 510(k)s with product code DRX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
Questions and answers
When was Sensi-Prema Neonatal ECG Electrodes, 40612,40614,40626,40550,40554,40555,440556,40610,40613,40625,40801 cleared by the FDA?
Sensi-Prema Neonatal ECG Electrodes, 40612,40614,40626,40550,40554,40555,440556,40610,40613,40625,40801 (K003804) received a 510(k) decision of Substantially Equivalent on August 30, 2001, 265 days after the submission was received.
What is the product code of K003804?
The FDA product code is DRX – Electrode, Electrocardiograph, a Class II (moderate risk) device regulated under 21 CFR 870.2360.