510(k) K101838
K101838 is an FDA 510(k) premarket notification submitted by Vuetek Scientific, LLC for the device "VTS1000". The FDA issued a decision of Substantially Equivalent on February 18, 2011. The device falls under product code KZA (Device, Vein Location, Liquid Crystal), a Class I device regulated under 21 CFR 880.6970.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 18, 2011
- Date Received
- July 1, 2010
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device, Vein Location, Liquid Crystal
- Device Class
- Class I
- Regulation Number
- 880.6970
- Review Panel
- HO
- Submission Type