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FDA 510(k) Application Details - K002388
Device Classification Name
System, Measurement, Blood-Pressure, Non-Invasive
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510(K) Number
K002388
Device Name
System, Measurement, Blood-Pressure, Non-Invasive
Applicant
CYBERCARE, INC.
7840 ROSWELL RD., SUITE 320
ATLANTA, GA 30350 US
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Contact
J. TERRY DRURY
Other 510(k) Applications for this Contact
Regulation Number
870.1130
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Classification Product Code
DXN
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/04/2000
Decision Date
08/25/2000
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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