The following data is part of a premarket notification filed by Xilas Medical, Inc. with the FDA for Vpt Meter.
Device ID | K030829 |
510k Number | K030829 |
Device Name: | VPT METER |
Classification | Device, Vibration Threshold Measurement |
Applicant | XILAS MEDICAL, INC. 12665 SILICON DR. San Antonio, TX 78249 |
Contact | Ruben G Zamorano |
Correspondent | Ruben G Zamorano XILAS MEDICAL, INC. 12665 SILICON DR. San Antonio, TX 78249 |
Product Code | LLN |
CFR Regulation Number | 882.1200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-03-14 |
Decision Date | 2003-12-05 |
Summary: | summary |