Electrode 3799
510(k) K831046
Electrode 3799 is a Class II device made by Medtronic Vascular, cleared under FDA 510(k) K831046 on 26 Apr 1983, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK831046 | Date26 Apr 1983 | StatusActive |
Official records
- FDA 510(k) database K831046
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- GXY
- Device class
- Class II
- Regulation
- 21 CFR Part 882.1320
- Advisory committee
- Neurology
- FDA decision
- SESE Substantially Equivalent
Similar devices
Other devices filed under FDA product code GXY (Electrode, Cutaneous).
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- DISPOSABLE CUTANEOUS ELECTRODES by Bio-Logic Systems Corp.
- EMPI MULTIDAY TENS DISPOSABLE ELECTRODE by Empi
- MONOTRODE CUTANEOUS ELECTRODE by Henley Intl.
- Garment Electrodes by Tone-A-Matic International, Inc.
- CONMED VERSA STEM NEUROMUSCULAR STIMULATION/TENS by Conmedcorp
- INDICATENS INDICATOR ELECTRODE MODEL 2 by Acudata Software
- TPK CUTANEOUS ELECTRODE by Staodyne, Inc.