The following data is part of a premarket notification filed by Leonhard Lang Gmbh with the FDA for Skintact Radiotransparent Multifunction Electrodes.
| Device ID | K103186 |
| 510k Number | K103186 |
| Device Name: | SKINTACT RADIOTRANSPARENT MULTIFUNCTION ELECTRODES |
| Classification | Automated External Defibrillators (non-wearable) |
| 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 | MKJ |
| CFR Regulation Number | 870.5310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-10-29 |
| Decision Date | 2011-02-08 |
| Summary: | summary |