Signa II Resting ECG Electrode
FDA 510(k) K862655 · Kone Instruments, Inc.
510(k) numberK862655
Submission
- Device name
- Signa II Resting ECG Electrode
- Applicant
- Kone Instruments, Inc.
Milton, WI, US - Received
- July 14, 1986
- Decision date
- August 6, 1986
- 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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More from Suzuken Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K873345 | 'Microlyte 4/5'JFP · Traditional | 09/11/1987SE |
| K870777 | Progress Plus Selective Chemistry AnalyzerJJF · Traditional | 03/13/1987SE |
| K863466 | M700 Stress MonitorDRT · Traditional | 12/22/1986SE |
| K860767 | Model E 600 ElectrocardiographDSI · Traditional | 04/23/1986SE |
| K853354 | Medic 4LDD · Traditional | 10/11/1985SE |
| K840200 | Progress Selective Dhemistry AnalyzJJF · Traditional | 04/04/1984SE |
| K830433 | Patient Monitor 575DRT · Traditional | 03/24/1983SE |
| K830432 | Central Station 590DRT · Traditional | 03/24/1983SE |
| K822952 | 560DRT · Traditional | 11/01/1982SE |
| K820541 | MicrolyteJJF · Traditional | 05/24/1982SE |
Questions and answers
When was Signa II Resting ECG Electrode cleared by the FDA?
Signa II Resting ECG Electrode (K862655) received a 510(k) decision of Substantially Equivalent on August 6, 1986, 23 days after the submission was received.
What is the product code of K862655?
The FDA product code is DRX – Electrode, Electrocardiograph, a Class II (moderate risk) device regulated under 21 CFR 870.2360.