Device Classification Name |
System, Measurement, Blood-Pressure, Non-Invasive
More FDA Info for this Device |
510(K) Number |
K033025 |
Device Name |
System, Measurement, Blood-Pressure, Non-Invasive |
Applicant |
TYTAN MEDICAL CORP.
1-3F, NO. 2, 1 LANE, JUANG
SHING RD. SEC. 1, WU GU 248
TAIPEI HSIEN, R.O.C. 248 TW
Other 510(k) Applications for this Company
|
Contact |
WILLIAM HSIEH
Other 510(k) Applications for this Contact |
Regulation Number |
870.1130
More FDA Info for this Regulation Number |
Classification Product Code |
DXN
Other 510(k) Applications for this Device
More FDA Info for this Product Code |
Date Received |
09/26/2003 |
Decision Date |
12/10/2003 |
Decision |
SESE - SUBST EQUIV |
Classification Advisory Committee |
CV - Cardiovascular |
Review Advisory Committee |
CV - Cardiovascular |
Statement / Summary / Purged Status |
Statement |
Type |
Traditional |
Reviewed By Third Party |
N |
Expedited Review |
|