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FDA 510(k) Application Details - K100315
Device Classification Name
Electrode, Electrocardiograph
More FDA Info for this Device
510(K) Number
K100315
Device Name
Electrode, Electrocardiograph
Applicant
I NEEDMD, INC
420 LEXINGTON AVENUE
SUITE 2400
NEW YORK, NY 10170 US
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Contact
IRVING L WIESEN, ESQ
Other 510(k) Applications for this Contact
Regulation Number
870.2360
More FDA Info for this Regulation Number
Classification Product Code
DRX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/04/2010
Decision Date
04/23/2010
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
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