SIEMENS INFINITY SC 6002XL ENHANCED WITH ST SEGMENT ANALYSIS


codes

Device Classification Name

monitor, st segment with alarm

510(k) Number K002105
Device Name SIEMENS INFINITY SC 6002XL ENHANCED WITH ST SEGMENT ANALYSIS
Original Applicant
SIEMENS MEDICAL SOLUTIONS USA, INC.
16 electronics ave.
danvers, 
MA 
01923

Original Contact penelope h greco
Regulation Number 870.1025
Classification Product Code
MLD  
Subsequent Product Codes
MHX   MSX  
Date Received 07/12/2000
Decision Date 12/05/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Anesthesiology

Type Traditional
Reviewed by Third Party No

Combination Product

No