ORG-9200A


codes

Device Classification Name

detector and alarm, arrhythmia

510(k) Number K002068
Device Name ORG-9200A
Original Applicant
NIHON KOHDEN AMERICA, INC.
90 icon st.
foothill ranch, 
CA 
92610 -1601

Original Contact bonnie bishop
Regulation Number 870.1025
Classification Product Code
DSI  
Date Received 07/07/2000
Decision Date 02/08/2001
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

Type Traditional
Reviewed by Third Party No

Combination Product

No