Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K071733
Device Classification Name
Electrocardiograph,Ambulatory(Without Analysis)
More FDA Info for this Device
510(K) Number
K071733
Device Name
Electrocardiograph,Ambulatory(Without Analysis)
Applicant
BRAEMAR, INC.
1285 CORPORATE CENTER DR.
SUITE 150
EAGAN, MN 55121 US
Other 510(k) Applications for this Company
Contact
DARREN DERSHEM
Other 510(k) Applications for this Contact
Regulation Number
870.2800
More FDA Info for this Regulation Number
Classification Product Code
MWJ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/26/2007
Decision Date
07/24/2007
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Statement
Type
Special
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact