LIFE SCOPE EC, MODEL BSM-1102


information about

Device Classification Name

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

510(k) Number K000517
Device Name LIFE SCOPE EC, MODEL BSM-1102
Original Applicant
NIHON KOHDEN AMERICA, INC.
2601 campus dr.
irvine, 
CA 
92612 -1601

Original Contact bonnie bishop
Regulation Number 870.1025
Classification Product Code
MHX  
Date Received 02/16/2000
Decision Date 08/31/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

Type Traditional
Reviewed by Third Party No

Combination Product

No