VER MED A10011 PNS DUAL ELEMENT ELECTRODE
FDA 510(k) clearance K921498 · decided 1993-06-09
Clearance details
- K-number
- K921498
- Device name
- VER MED A10011 PNS DUAL ELEMENT ELECTRODE
- Applicant
- Vermont Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1992-03-31
- Decision date
- 1993-06-09
- Days to decision
- 435 days
- Clearance type
- Traditional
- Product code
- BXM
- Device class
- 2
- Regulation number
- 868.2775
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Bellows Falls, VT, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| MODIFIED INS-1 INTRAOPERATIVE NERVE SURVEILLANCE SYSTEM (K013215) | Nuvasive, Inc. | 2001-10-16 |
| NUVASIVE INS-1 INTRAOPERATIVE NERVE SURVEILLANCE SYSTEM (K002677) | Nuvasive, Inc. | 2000-11-13 |
| MODEL SKCK STERILE KNOB COVER KIT (K870662) | Life-Tech Intl., Inc. | 1987-10-28 |
Recalls involving this device
No recalls on record reference this clearance.