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FDA 510(k) Application Details - K960499
Device Classification Name
Transmitters And Receivers, Electrocardiograph, Telephone
More FDA Info for this Device
510(K) Number
K960499
Device Name
Transmitters And Receivers, Electrocardiograph, Telephone
Applicant
UNIVERSAL MEDICAL, INC.
1760 MARKET ST.
13TH FLOOR
PHILADELPHIA, PA 19103 US
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Contact
MARGARET S LURIO
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Regulation Number
870.2920
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Classification Product Code
DXH
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More FDA Info for this Product Code
Date Received
02/02/1996
Decision Date
08/06/1996
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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