OXYVU -1 HYPERSPECTRAL TISSUE OXYGENATION (HTO) MEASUREMENT SYSTEM


Device Classification Name

oximeter, tissue saturation

510(k) Number K073656
Device Name OXYVU -1 HYPERSPECTRAL TISSUE OXYGENATION (HTO) MEASUREMENT SYSTEM
Applicant
HYPERMED, INC.
11 mystic ave.
winchester, 
MA 
01890 -2920

Applicant Contact chas burr
Correspondent
HYPERMED, INC.
11 mystic ave.
winchester, 
MA 
01890 -2920

Correspodent Contact chas burr
Regulation Number 870.2700
Classification Product Code
MUD  
Date Received 12/26/2007
Decision Date 01/25/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No