SIEMENS INFINITY MODULAR MONITORS, MODELS SC 8000, SC 7000 & SC 9000XL & SIEMENS INFINITY EXPLORER


Device Classification Name

monitor, physiological, patient(with arrhythmia detection or alarms)

510(k) Number K022889
Device Name SIEMENS INFINITY MODULAR MONITORS, MODELS SC 8000, SC 7000 & SC 9000XL & SIEMENS INFINITY EXPLORER
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
MHX  
Date Received 08/30/2002
Decision Date 09/25/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No