VITERION 100 TELEHEALTH MONITOR


Device Classification Name

monitor,physiological,patient(without arrhythmia detection or alarms)

510(k) Number K030419
Device Name VITERION 100 TELEHEALTH MONITOR
Applicant
VITERION TELEHEALTHCARE LLC
555 white plains rd.
tarrytown, 
NY 
10591

Applicant Contact thuy nguyen
Correspondent
VITERION TELEHEALTHCARE LLC
555 white plains rd.
tarrytown, 
NY 
10591

Correspodent Contact thuy nguyen
Regulation Number 870.2300
Classification Product Code
MWI  
Date Received 02/10/2003
Decision Date 11/06/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls