MEL-16-1, MEL-16-3 & MEL-16-5 TDK ECG Electrodes
FDA 510(k) K863369 · Tdk Corp.
510(k) numberK863369
Submission
- Device name
- MEL-16-1, MEL-16-3 & MEL-16-5 TDK ECG Electrodes
- Applicant
- Tdk Corp.
Chicago, IL, US - Received
- July 24, 1986
- Decision date
- January 6, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DRX – Electrode, Electrocardiograph
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2360
- Specialty
- Cardiovascular
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| 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 |
|---|---|---|
| K883643 | TDK ECG Electrode, MEL-10LDRX · Traditional | 11/17/1988SE |
| K882904 | TDK Electrode MEL-20-1, MEL-20-3, MEL-20-5DRX · Traditional | 10/05/1988SE |
| K870834 | TDK ECG Electrode MEL-10DRX · Traditional | 03/23/1987SE |
| K854596 | TDK ECG Electrode MEL-08-09 & -11DRS · Traditional | 05/07/1986SE |
| K833899 | TDK ECG Electrode MEL-08DRX · Traditional | 02/10/1984SE |
Questions and answers
When was MEL-16-1, MEL-16-3 & MEL-16-5 TDK ECG Electrodes cleared by the FDA?
MEL-16-1, MEL-16-3 & MEL-16-5 TDK ECG Electrodes (K863369) received a 510(k) decision of Substantially Equivalent on January 6, 1987, 166 days after the submission was received.
What is the product code of K863369?
The FDA product code is DRX – Electrode, Electrocardiograph, a Class II (moderate risk) device regulated under 21 CFR 870.2360.