FORE-SIGHT ABSOLUTE TISSUE OXIMETER


Device Classification Name

oximeter, tissue saturation

510(k) Number K112820
Device Name FORE-SIGHT ABSOLUTE TISSUE OXIMETER
Applicant
CAS MEDICAL SYSTEMS, INC.
44 east industrial rd.
branford, 
CT 
06405

Applicant Contact ron jeffrey
Correspondent
CAS MEDICAL SYSTEMS, INC.
44 east industrial rd.
branford, 
CT 
06405

Correspodent Contact ron jeffrey
Regulation Number 870.2700
Classification Product Code
MUD  
Date Received 09/28/2011
Decision Date 01/26/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Neurology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No