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FDA 510(k) Application Details - K062677
Device Classification Name
Electrocardiograph
More FDA Info for this Device
510(K) Number
K062677
Device Name
Electrocardiograph
Applicant
MORTARA INSTRUMENT, INC.
7865 NORTH 86TH ST.
MILWAUKEE, WI 53224 US
Other 510(k) Applications for this Company
Contact
HARLAN VAN MATRE
Other 510(k) Applications for this Contact
Regulation Number
870.2340
More FDA Info for this Regulation Number
Classification Product Code
DPS
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/08/2006
Decision Date
11/15/2006
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
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