The following data is part of a premarket notification filed by Leonhard Lang Gmbh with the FDA for Skintact Pre-wired Ecg Electrodes With Conductive Adhesive.
| Device ID | K080106 |
| 510k Number | K080106 |
| Device Name: | SKINTACT PRE-WIRED ECG ELECTRODES WITH CONDUCTIVE ADHESIVE |
| 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 | 2008-01-15 |
| Decision Date | 2008-02-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884838007936 | K080106 | 000 |
| 20884838007929 | K080106 | 000 |
| 20884838007905 | K080106 | 000 |
| 20884838007899 | K080106 | 000 |
| 20884838007882 | K080106 | 000 |
| 20884838007868 | K080106 | 000 |
| 10884838009452 | K080106 | 000 |