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FDA 510(k) Application Details - K081437
Device Classification Name
Electrocardiograph
More FDA Info for this Device
510(K) Number
K081437
Device Name
Electrocardiograph
Applicant
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
9900 INNOVATION DR.
RP-2122
WAUWATOSA, WI 53226 US
Other 510(k) Applications for this Company
Contact
MARGARET MUCHA
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
05/22/2008
Decision Date
07/15/2008
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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