| Device Classification Name |
System, Measurement, Blood-Pressure, Non-Invasive
More FDA Info for this Device |
| 510(K) Number |
K033397 |
| Device Name |
System, Measurement, Blood-Pressure, Non-Invasive |
| Applicant |
AVITA CORPORATION
9F, NO. 78, SEC. 1,
KWANG-FU RD.
SAN-CHUNG, TAIPEI COUNTY 241 TW
Other 510(k) Applications for this Company
|
| Contact |
GEO LIN
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 |
10/24/2003 |
| Decision Date |
04/09/2004 |
| Decision |
SESE - SUBST EQUIV |
| Classification Advisory Committee |
CV - Cardiovascular |
| Review Advisory Committee |
CV - Cardiovascular |
| Statement / Summary / Purged Status |
Summary |
| Type |
Traditional |
| Reviewed By Third Party |
N |
| Expedited Review |
|