ANESTHESIA MONITOR; BEDSIDE MONITOR, SERIES BSM-5130A


Device Classification Name

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

510(k) Number K030105
Device Name ANESTHESIA MONITOR; BEDSIDE MONITOR, SERIES BSM-5130A
Original Applicant
NIHON KOHDEN AMERICA, INC.
90 icon st.
foothill ranch, 
CA 
92610 -1601

Original Contact serrah namini
Regulation Number 870.1025
Classification Product Code
MHX  
Date Received 01/13/2003
Decision Date 03/04/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No