Nikomed Trace 1 ECG Electrodes
FDA 510(k) K022909 · Nikomed U.S.A., Inc.
510(k) numberK022909
Submission
- Device name
- Nikomed Trace 1 ECG Electrodes
- Applicant
- Nikomed U.S.A., Inc.
Stillwater, MN, US - Received
- September 3, 2002
- Decision date
- January 9, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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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| K950472 | Disposable ECG Monitoring Electrode #4110 45MM, #4140 35MMDRX · Traditional | 11/14/1995SE |
| K950480 | Disposable ECG Monitoring Electrode #4539 28X45MMDRX · Traditional | 11/06/1995SE |
| K950478 | Disposable ECG Monitoring Electrode #4570 38X60MMDRX · Traditional | 11/06/1995SE |
| K950477 | Disposable ECG Monitoring Electrode #4560 38X60MMDRX · Traditional | 11/06/1995SE |
| K950474 | Disposable ECG Monitoring Electrode #4533 32X45MMDRX · Traditional | 11/06/1995SE |
| K950471 | Disposable ECG Monitoring Electrode #4580 32X45MMDRX · Traditional | 11/06/1995SE |
| K950470 | Disposable ECG Monitoring Electrode #4535 32X45MMDRX · Traditional | 11/06/1995SE |
Questions and answers
When was Nikomed Trace 1 ECG Electrodes cleared by the FDA?
Nikomed Trace 1 ECG Electrodes (K022909) received a 510(k) decision of Substantially Equivalent on January 9, 2003, 128 days after the submission was received.
What is the product code of K022909?
The FDA product code is DRX – Electrode, Electrocardiograph, a Class II (moderate risk) device regulated under 21 CFR 870.2360.