STOCKERT COMPACT SYSTEM VERSION 2.0

codes

Device Classification Name

console, heart-lung machine, cardiopulmonary bypass

510(k) Number K002118
Device Name STOCKERT COMPACT SYSTEM VERSION 2.0
Original Applicant
STOECKERT INSTRUMENTE
49 plain st.
north attleboro, 
MA 
02760

Original Contact cynthia j. m. nolte
Regulation Number 870.4220
Classification Product Code
DTQ  
Date Received 07/13/2000
Decision Date 08/09/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

Type Special
Reviewed by Third Party No

Combination Product

No