Device Classification Name |
monitor, physiological, patient (without arrhythmia detection or alarms)
|
510(k) Number |
K101259 |
Device Name |
V-TRUST TD-8002 MULTI-PARAMETER SPOT-CHECK MONITOR MODEL TD-8002 |
Applicant |
TaiDoc Technology Corporation |
6F, NO. 127, WUGONG 2ND RD |
WUGU TOWNSHIP |
TAIPEI COUNTY,
TW
24888
|
|
Applicant Contact |
DEBRA LIANG |
Correspondent |
TaiDoc Technology Corporation |
6F, NO. 127, WUGONG 2ND RD |
WUGU TOWNSHIP |
TAIPEI COUNTY,
TW
24888
|
|
Correspondent Contact |
DEBRA LIANG |
Regulation Number | 870.2300
|
Classification Product Code |
|
Date Received | 05/04/2010 |
Decision Date | 06/17/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|