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FDA 510(k) Application Details - K100310
Device Classification Name
Electrocardiograph,Ambulatory(Without Analysis)
More FDA Info for this Device
510(K) Number
K100310
Device Name
Electrocardiograph,Ambulatory(Without Analysis)
Applicant
BTL INDUSTRIES, INC
1705 S. CAPITAL OF TEXAS HWY
SUITE 500
AUSTIN, TX 78746 US
Other 510(k) Applications for this Company
Contact
RICHARD VINCINS, CQA, RAC (US,EU)
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
02/03/2010
Decision Date
10/13/2010
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
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