Ver Med A10011 PNS Dual Element Electrode
FDA 510(k) K921498 · Vermont Medical, Inc.
510(k) numberK921498
Submission
- Device name
- Ver Med A10011 PNS Dual Element Electrode
- Applicant
- Vermont Medical, Inc.
Bellows Falls, VT, US - Received
- March 31, 1992
- Decision date
- June 9, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- BXM – Stimulator, Nerve, Ac-Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.2775
- Specialty
- Anesthesiology
Other 510(k)s with product code BXM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K013215 | Modified INS-1 Intraoperative Nerve Surveillance SystemBXM · Special | Nuvasive, Inc. | 10/16/2001SE |
| K002677 | Nuvasive INS-1 Intraoperative Nerve Surveillance SystemBXM · Traditional | Nuvasive, Inc. | 11/13/2000SE |
| K870662 | Model SKCK Sterile Knob Cover KitBXM · Traditional | Life-Tech Intl., Inc. | 10/28/1987SE |
More from Life-Tech Intl., Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K030073 | Vermed A10021 Resting EKG Tab ElectrodeDRX · Special | 03/28/2003SE |
| K021537 | Multipurpose Neuroplus Electrode, Model A10005GXY · Traditional | 03/03/2003SE |
| K010638 | Neuroplus, Model A10040, A10041, A10042, A10043GXY · Traditional | 05/03/2001SE |
| K915831 | Thermal Probe CoverFMT · Traditional | 06/08/1992SE |
| K911687 | Ver-Med A10020 Resting EKG ElectrodeDRX · Traditional | 10/10/1991SE |
| K910139 | Ver-Med A10014 Resting EKG Electrode & A10021DRX · Traditional | 08/15/1991SE |
| K905489 | Ver-Med A10017 Universal ElectrodeDRX · Traditional | 03/21/1991SE |
| K781430 | Pregelled Disposable E.K.G. ElectrodeDRX · Traditional | 10/31/1978SE |
Questions and answers
When was Ver Med A10011 PNS Dual Element Electrode cleared by the FDA?
Ver Med A10011 PNS Dual Element Electrode (K921498) received a 510(k) decision of Substantially Equivalent on June 9, 1993, 435 days after the submission was received.
What is the product code of K921498?
The FDA product code is BXM – Stimulator, Nerve, Ac-Powered, a Class II (moderate risk) device regulated under 21 CFR 868.2775.