CENTURY SERIES HOLTER SCANNER SYSTEM, MODELS C3000, C2000 AND C1000


Device Classification Name

electrocardiograph, ambulatory, with analysis algorithm

510(k) Number K024323
Device Name CENTURY SERIES HOLTER SCANNER SYSTEM, MODELS C3000, C2000 AND C1000
Original Applicant
BIOMEDICAL SYSTEMS CORP.
2464 west port plaza dr.
st. louis, 
MO 
63146

Original Contact k. michael kroehnke
Regulation Number 870.2800
Classification Product Code
MLO  
Date Received 12/26/2002
Decision Date 06/30/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No