The following data is part of a premarket notification filed by Multi Biosensors, Inc. with the FDA for Electrocardiogram Dispos. Electrode Pad.
| Device ID | K842514 |
| 510k Number | K842514 |
| Device Name: | ELECTROCARDIOGRAM DISPOS. ELECTRODE PAD |
| Classification | Electrode, Electrocardiograph |
| Applicant | MULTI BIOSENSORS, INC. P.O. BOX 12264 El Paso, TX 79913 |
| Contact | Manoli |
| Correspondent | Manoli MULTI BIOSENSORS, INC. P.O. BOX 12264 El Paso, TX 79913 |
| Product Code | DRX |
| CFR Regulation Number | 870.2360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-06-26 |
| Decision Date | 1985-03-01 |