Blue Sensor Supatab,Disposable ECG Electrodes
FDA 510(k) K983689 · Medicotest A/S
510(k) numberK983689
Submission
- Device name
- Blue Sensor Supatab,Disposable ECG Electrodes
- Applicant
- Medicotest A/S
Washington, DC, US - Received
- October 20, 1998
- Decision date
- January 15, 1999
- 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
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 |
More from Suzuken Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K020382 | Blue Sensor, Disposable ECG Electrodes for AnaesthesiaDRX · Traditional | 06/28/2002SE |
| K020907 | Neuroline, Subdermal Needle ElectrodesIKT · Traditional | 06/14/2002SE |
| K002079 | Multi-Function Defibrillation ElectrodeMKJ · Traditional | 02/22/2001SE |
| K001869 | Diagnostic Electromyography Needle Electrode, Disposable Hypodermic NeedleIKT · Traditional | 09/18/2000SE |
| K973529 | Neuroline, Disposable Concentric Needle ElectrodesIKT · Traditional | 11/20/1997SE |
| K965194 | Medicom, TENS ElectrodesGXY · Traditional | 03/06/1997SE |
Questions and answers
When was Blue Sensor Supatab,Disposable ECG Electrodes cleared by the FDA?
Blue Sensor Supatab,Disposable ECG Electrodes (K983689) received a 510(k) decision of Substantially Equivalent on January 15, 1999, 87 days after the submission was received.
What is the product code of K983689?
The FDA product code is DRX – Electrode, Electrocardiograph, a Class II (moderate risk) device regulated under 21 CFR 870.2360.