The following data is part of a premarket notification filed by Vermont Medical, Inc. with the FDA for Pregelled Disposable E.k.g. Electrode.
| Device ID | K781430 |
| 510k Number | K781430 |
| Device Name: | PREGELLED DISPOSABLE E.K.G. ELECTRODE |
| Classification | Electrode, Electrocardiograph |
| Applicant | VERMONT MEDICAL, INC. 9 LOVELL DRIVE Bellows Falls, VT 05101 -0556 |
| Product Code | DRX |
| CFR Regulation Number | 870.2360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-08-21 |
| Decision Date | 1978-10-31 |