510(k) K921498
- Device
- VER MED A10011 PNS DUAL ELEMENT ELECTRODE
- Applicant
- VERMONT MEDICAL, INC.
- 510(k) number
- K921498
- Product code
- BXM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1993-06-09
- Date received
- 1992-03-31
- Regulation
- 868.2775
- Classification name
- Stimulator, Nerve, Ac-powered
- Medical specialty
- Anesthesiology
- Review panel
- Anesthesiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- PAMELA SOPCZYK
- Address
- Industrial Park Bellows Falls VT US 05101 05101
FDA Registration Numbers#
- 2032098
- 2031966
- 3030412764
- 2011115
Source Documents#
Other 510(k) Records For Product Code BXM #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K013215 | MODIFIED INS-1 INTRAOPERATIVE NERVE SURVEILLANCE SYSTEM | Nuvasive, Inc. | 2001-10-16 |
| K002677 | NUVASIVE INS-1 INTRAOPERATIVE NERVE SURVEILLANCE SYSTEM | Nuvasive, Inc. | 2000-11-13 |
| K870662 | MODEL SKCK STERILE KNOB COVER KIT | Life-Tech Intl., Inc. | 1987-10-28 |
Legacy Summary#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases