The following data is part of a premarket notification filed by Leon H. Lang Co. with the FDA for Skintact Ag Electrodes.
| Device ID | K862618 |
| 510k Number | K862618 |
| Device Name: | SKINTACT AG ELECTRODES |
| Classification | Electrode, Electrocardiograph |
| Applicant | LEON H. LANG CO. 6010 INNSBRUCK AUSTRIA Archenweg, 56, AT |
| Contact | Leonhard Lang |
| Correspondent | Leonhard Lang LEON H. LANG CO. 6010 INNSBRUCK AUSTRIA Archenweg, 56, AT |
| Product Code | DRX |
| CFR Regulation Number | 870.2360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-07-09 |
| Decision Date | 1986-09-15 |