Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K100940
Device Classification Name
System, Measurement, Blood-Pressure, Non-Invasive
More FDA Info for this Device
510(K) Number
K100940
Device Name
System, Measurement, Blood-Pressure, Non-Invasive
Applicant
ANDON HEALTH CO.,LTD
NO 3, JIN PING STREET
NANKAI DISTRICT
TIANJIN 300190 CN
Other 510(k) Applications for this Company
Contact
LIU YI
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
04/05/2010
Decision Date
06/29/2010
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact