MOBILE CAREGUIDE 2100 OXIMETER


Device Classification Name

oximeter, tissue saturation

510(k) Number K122645
Device Name MOBILE CAREGUIDE 2100 OXIMETER
Applicant
REFLECTANCE MEDICAL INC
116 flaunders road,
suite 1000
westborough, 
MA 
01581

Applicant Contact nandini murthy
Correspondent
REFLECTANCE MEDICAL INC
116 flaunders road,
suite 1000
westborough, 
MA 
01581

Correspodent Contact nandini murthy
Regulation Number 870.2700
Classification Product Code
MUD  
Date Received 08/30/2012
Decision Date 12/05/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No