Device Classification Name |
Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
|
510(k) Number |
K043368 |
Device Name |
VITELCARE TURTLE, MODEL 400 |
Applicant |
VISUAL TELECOMMUNICATIONS NETWORK, INC. |
8201 GREENSBORO DR., STE. 600 |
MCLEAN,
VA
22102
|
|
Applicant Contact |
ALLEN IZADPANAH |
Correspondent |
VISUAL TELECOMMUNICATIONS NETWORK, INC. |
8201 GREENSBORO DR., STE. 600 |
MCLEAN,
VA
22102
|
|
Correspondent Contact |
ALLEN IZADPANAH |
Regulation Number | 870.2300
|
Classification Product Code |
|
Date Received | 12/08/2004 |
Decision Date | 02/01/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|