The following data is part of a premarket notification filed by Multi Biosensors, Inc. with the FDA for Additional Use For Ecg Disposable Electrode V-pad.
| Device ID | K864690 |
| 510k Number | K864690 |
| Device Name: | ADDITIONAL USE FOR ECG DISPOSABLE ELECTRODE V-PAD |
| Classification | Electrode, Electrocardiograph |
| Applicant | MULTI BIOSENSORS, INC. P.O. BOX 12264 El Paso, TX 79913 |
| Contact | Dr. S Manoli |
| Correspondent | Dr. S 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 | 1986-12-02 |
| Decision Date | 1987-05-06 |