KZA · Device, Vein Location, Liquid Crystal
General Hospital · 21 CFR 880.6970 · Class 1
Overview
| Product Code | KZA |
|---|---|
| Device Name | Device, Vein Location, Liquid Crystal |
| Regulation | 21 CFR 880.6970 |
| Device Class | Class 1 |
| Review Panel | General Hospital |
Identification
A liquid crystal vein locator is a device used to indicate the location of a vein by revealing variations in the surface temperature of the skin by displaying the color changes of heat sensitive liquid crystals (cholesteric esters).
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9.
Recent Cleared Devices (6 of 6)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K152088 | IV-eye | Novarix Limited | Feb 24, 2016 | SESE |
| K101838 | VTS1000 | Vuetek Scientific, LLC | Feb 18, 2011 | SESE |
| K042679 | IR VIEWER | Infrared Imaging Systems, Inc. | Dec 10, 2004 | SESE |
| K982612 | ESP7 VENOUS IMAGE | Ironmaster, Inc. | Dec 14, 1998 | SESE |
| K780884 | HYPO-GRIP | Harco Products | Aug 10, 1978 | SESE |
| K780883 | E-Z-JECTOR | Harco Products | Aug 10, 1978 | SESE |
Top Applicants
- Harco Products — 2 clearances
- Infrared Imaging Systems, Inc. — 1 clearance
- Ironmaster, Inc. — 1 clearance
- Novarix Limited — 1 clearance
- Vuetek Scientific, LLC — 1 clearance
