INVOS CEREBRAL/SOMATIC OXIMETER SYSTEM, MODEL 5100C


Device Classification Name

oximeter, tissue saturation

510(k) Number K080769
Device Name INVOS CEREBRAL/SOMATIC OXIMETER SYSTEM, MODEL 5100C
Applicant
SOMANETICS CORP.
1653 east maple rd.
troy, 
MI 
48083 -4208

Applicant Contact ronald a widman
Correspondent
SOMANETICS CORP.
1653 east maple rd.
troy, 
MI 
48083 -4208

Correspodent Contact ronald a widman
Regulation Number 870.2700
Classification Product Code
MUD  
Date Received 03/18/2008
Decision Date 05/14/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No