The following data is part of a premarket notification filed by Nikomed U.s.a., Inc. with the FDA for Nikomed Trace 1 Ecg Electrodes.
| Device ID | K022909 |
| 510k Number | K022909 |
| Device Name: | NIKOMED TRACE 1 ECG ELECTRODES |
| Classification | Electrode, Electrocardiograph |
| Applicant | NIKOMED U.S.A., INC. P.O. BOX 560 Stillwater, MN 55082 |
| Contact | Elaine Duncan |
| Correspondent | Elaine Duncan NIKOMED U.S.A., INC. P.O. BOX 560 Stillwater, MN 55082 |
| Product Code | DRX |
| CFR Regulation Number | 870.2360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-09-03 |
| Decision Date | 2003-01-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30853512006487 | K022909 | 000 |
| 00853512006806 | K022909 | 000 |