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
|
|
Correspondent Contact |
THUY NGUYEN |
Regulation Number | 870.2300
|
Classification Product Code |
|
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
|
|
|