DYNAMIC NEUROSCREENING DEVICE
FDA 510(k) clearance K141208 · decided 2014-07-23
Clearance details
- K-number
- K141208
- Device name
- DYNAMIC NEUROSCREENING DEVICE
- Applicant
- Prosenex
- Decision
- Substantially Equivalent
- Date received
- 2014-05-09
- Decision date
- 2014-07-23
- Days to decision
- 75 days
- Clearance type
- Traditional
- Product code
- LQW
- Device class
- 1
- Regulation number
- 882.1200
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Leola, PA, 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 |
|---|---|---|
| TSA 2001 THERMAL SENSORY ANALYZER (K922052) | Medoc Corp. | 1993-10-21 |
| NTE-2 THERMAL SENSITIVITY TESTER (K864345) | Sensortek, Inc. | 1987-01-29 |
Recalls involving this device
No recalls on record reference this clearance.