NETKONNECT REMOTE NETWORK EXTENSION


Device Classification Name

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

510(k) Number K112637
Device Name NETKONNECT REMOTE NETWORK EXTENSION
Applicant
NIHON KOHDEN
90 icon
foothill ranch, 
CA 
92610

Applicant Contact steve geerdes
Correspondent
NIHON KOHDEN
90 icon
foothill ranch, 
CA 
92610

Correspodent Contact steve geerdes
Regulation Number 870.1025
Classification Product Code
MHX  
Date Received 09/09/2011
Decision Date 12/09/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No