The following data is part of a premarket notification filed by Leonhard Lang Gmbh with the FDA for Skintact Ecg Electrode.
| Device ID | K040249 |
| 510k Number | K040249 |
| Device Name: | SKINTACT ECG ELECTRODE |
| Classification | Electrode, Electrocardiograph |
| Applicant | LEONHARD LANG GMBH P.O. BOX 560 Stillwater, MN 55082 -0560 |
| Contact | Elaine Duncan |
| Correspondent | Elaine Duncan LEONHARD LANG GMBH P.O. BOX 560 Stillwater, MN 55082 -0560 |
| Product Code | DRX |
| CFR Regulation Number | 870.2360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-02-03 |
| Decision Date | 2004-02-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884838002535 | K040249 | 000 |