The following data is part of a premarket notification filed by Vuetek Scientific Llc with the FDA for Vts1000.
Device ID | K101838 |
510k Number | K101838 |
Device Name: | VTS1000 |
Classification | Device, Vein Location, Liquid Crystal |
Applicant | VUETEK SCIENTIFIC LLC 1733 CANTON LANE SUITE B Marietta, GA 30062 -2679 |
Contact | Paul Sumner |
Correspondent | Paul Sumner VUETEK SCIENTIFIC LLC 1733 CANTON LANE SUITE B Marietta, GA 30062 -2679 |
Product Code | KZA |
CFR Regulation Number | 880.6970 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-07-01 |
Decision Date | 2011-02-18 |
Summary: | summary |