The following data is part of a premarket notification filed by Vermont Medical, Inc. with the FDA for Ver-med A10017 Universal Electrode.
| Device ID | K905489 |
| 510k Number | K905489 |
| Device Name: | VER-MED A10017 UNIVERSAL ELECTRODE |
| Classification | Electrode, Electrocardiograph |
| Applicant | VERMONT MEDICAL, INC. INDUSTRIAL PARK Bellows Falls, VT 05101 |
| Contact | David Lovell |
| Correspondent | David Lovell VERMONT MEDICAL, INC. INDUSTRIAL PARK Bellows Falls, VT 05101 |
| Product Code | DRX |
| CFR Regulation Number | 870.2360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-12-07 |
| Decision Date | 1991-03-21 |