BIOTREND OXYGEN SATURATION & HEMATOCRIT SYSTEM


Device Classification Name

sensor, blood-gas, in-line, cardiopulmonary bypass

510(k) Number K954501
Device Name BIOTREND OXYGEN SATURATION & HEMATOCRIT SYSTEM
Applicant
MEDTRONIC BIO-MEDICUS, INC.
9600 west 76th st.
eden prairie, 
MN 
55344

Applicant Contact thomas k johnsen
Correspondent
MEDTRONIC BIO-MEDICUS, INC.
9600 west 76th st.
eden prairie, 
MN 
55344

Correspodent Contact thomas k johnsen
Regulation Number 870.4410
Classification Product Code
DTY  
Date Received 09/28/1995
Decision Date 01/16/1996
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

Type Traditional
Reviewed by Third Party No

Combination Product

No