Last synced on 18 April 2025 at 11:05 pm

Device, Vein Location, Liquid Crystal

Page Type
Product Code
Regulation Medical Specialty
General Hospital
Review Panel
General Hospital
Submission Type
510(K) Exempt
Device Classification
Class 1
Regulation Number
880.6970
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 880.6970 Liquid crystal vein locator

§ 880.6970 Liquid crystal vein locator.

(a) 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).

(b) Classification. 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.

[45 FR 69682, Oct. 21, 1980, as amended at 54 FR 25050, June 12, 1989; 66 FR 38807, July 25, 2001]

Device, Vein Location, Liquid Crystal

Page Type
Product Code
Regulation Medical Specialty
General Hospital
Review Panel
General Hospital
Submission Type
510(K) Exempt
Device Classification
Class 1
Regulation Number
880.6970
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 880.6970 Liquid crystal vein locator

§ 880.6970 Liquid crystal vein locator.

(a) 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).

(b) Classification. 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.

[45 FR 69682, Oct. 21, 1980, as amended at 54 FR 25050, June 12, 1989; 66 FR 38807, July 25, 2001]