ECG Electrode
FDA 510(k) K944655 · Conmed Andover Medical, Inc.
510(k) numberK944655
Submission
- Device name
- ECG Electrode
- Applicant
- Conmed Andover Medical, Inc.
Haverhill, MA, US - Received
- September 21, 1994
- Decision date
- November 22, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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
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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 |
|---|---|---|
| K945836 | 1800 Monitoring ECG Electrode and 1870 Diaphoretic Monitoring ECG ElectrodesDRX · Traditional | 06/20/1995SE |
| K946273 | 1700 Monitoring ECG ElectrodeDRX · Traditional | 05/17/1995SE |
| K944726 | 1710 Monitoring ECG ElectrodeDRX · Traditional | 11/22/1994SE |
| K944849 | 2700 Cleartrace Radiotranslucent Monitoring ECG ElectrobeDRX · Traditional | 10/17/1994SE |
| K942718 | Cloth Tens/Bnes ElectrodeGXY · Traditional | 09/22/1994SE |
| K941839 | Disposable Surgical CableDSA · Traditional | 07/27/1994SE |
| K942925 | Conmed Andover Med ECG ElectrodesDRX · Traditional | 07/20/1994SE |
Questions and answers
When was ECG Electrode cleared by the FDA?
ECG Electrode (K944655) received a 510(k) decision of Substantially Equivalent on November 22, 1994, 62 days after the submission was received.
What is the product code of K944655?
The FDA product code is DRX – Electrode, Electrocardiograph, a Class II (moderate risk) device regulated under 21 CFR 870.2360.