Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K100763
Device Classification Name
System, Measurement, Blood-Pressure, Non-Invasive
More FDA Info for this Device
510(K) Number
K100763
Device Name
System, Measurement, Blood-Pressure, Non-Invasive
Applicant
MICROLIFE INTELLECTUAL PROPERTY GMBH
55 NORTHERN BLVD., SUITE 200
GREAT NECK, NY 11021 US
Other 510(k) Applications for this Company
Contact
SUSAN D GOLDSTEIN-FALK
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
03/17/2010
Decision Date
08/27/2010
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact