GE MARQUETTE MEDICAL SYSTEMS PRUCKA CARDIOLAB CATH SYSTEM, VERSION 1.11


information about

Device Classification Name

electrocardiograph

510(k) Number K000645
Device Name GE MARQUETTE MEDICAL SYSTEMS PRUCKA CARDIOLAB CATH SYSTEM, VERSION 1.11
Original Applicant
GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN
13000 executive dr.
sugarland, 
TX 
77478

Original Contact ian mcdonald
Regulation Number 870.2340
Classification Product Code
DPS  
Date Received 02/25/2000
Decision Date 05/24/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

Type Traditional
Reviewed by Third Party No

Combination Product

No