The following data is part of a premarket notification filed by Leonhard Lang Co. with the FDA for Skintact Ecg Electrodes, S&w Ecg Electrodes.
| Device ID | K982521 |
| 510k Number | K982521 |
| Device Name: | SKINTACT ECG ELECTRODES, S&W ECG ELECTRODES |
| Classification | Electrode, Electrocardiograph |
| Applicant | LEONHARD LANG CO. ARCHENWEG 56 Innsbruck, AT A-6010 |
| Contact | Burrhus Lang |
| Product Code | DRX |
| CFR Regulation Number | 870.2360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 1998-07-20 |
| Decision Date | 1999-10-26 |
| Summary: | summary |