TDK ECG Electrode, MEL-10L
FDA 510(k) K883643 · Tdk Corp.
510(k) numberK883643
Submission
- Device name
- TDK ECG Electrode, MEL-10L
- Applicant
- Tdk Corp.
272 01, Japan, JP - Received
- August 23, 1988
- Decision date
- November 17, 1988
- 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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| 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 |
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| K092389 | Disposal ECG Electrodes, Model EasyrodeDRX · Traditional | Suzuken Co., Ltd. | 10/13/2009SE |
More from Suzuken Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| 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 |
| K863369 | MEL-16-1, MEL-16-3 & MEL-16-5 TDK ECG ElectrodesDRX · Traditional | 01/06/1987SE |
| 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 TDK ECG Electrode, MEL-10L cleared by the FDA?
TDK ECG Electrode, MEL-10L (K883643) received a 510(k) decision of Substantially Equivalent on November 17, 1988, 86 days after the submission was received.
What is the product code of K883643?
The FDA product code is DRX – Electrode, Electrocardiograph, a Class II (moderate risk) device regulated under 21 CFR 870.2360.