K030829 is an FDA 510(k) clearance for the VPT METER. This device is classified as a Device, Vibration Threshold Measurement (Class I - General Controls, product code LLN).
Submitted by Xilas Medical, Inc. (San Antonio, US). The FDA issued a Cleared decision on December 5, 2003, 266 days after receiving the submission on March 14, 2003.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1200.
| 510(k) Number | K030829 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 14, 2003 |
| Decision Date | December 05, 2003 |
| Days to Decision | 266 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | LLN — Device, Vibration Threshold Measurement |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 882.1200 |