The following data is part of a premarket notification filed by Alternative Design Systems, Inc. with the FDA for 5000 Series Ecg Electrodes.
| Device ID | K854757 |
| 510k Number | K854757 |
| Device Name: | 5000 SERIES ECG ELECTRODES |
| Classification | Electrode, Electrocardiograph |
| Applicant | ALTERNATIVE DESIGN SYSTEMS, INC. 419 HACKENSACK AVE. Carlstadt, NJ 07072 |
| Contact | John L Essmyer |
| Correspondent | John L Essmyer ALTERNATIVE DESIGN SYSTEMS, INC. 419 HACKENSACK AVE. Carlstadt, NJ 07072 |
| Product Code | DRX |
| CFR Regulation Number | 870.2360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-11-27 |
| Decision Date | 1986-04-23 |