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FDA 510(k) Application Details - K030136
Device Classification Name
Monitor, Electric For Gravity Flow Infusion Systems
More FDA Info for this Device
510(K) Number
K030136
Device Name
Monitor, Electric For Gravity Flow Infusion Systems
Applicant
DRIP ALERT, INC.
500 E. BROWARD BLVD.
SUITE 1400
FT. LAUDERDALE, FL 33394 US
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Contact
POLLY D HESEMAN
Other 510(k) Applications for this Contact
Regulation Number
880.2420
More FDA Info for this Regulation Number
Classification Product Code
FLN
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/14/2003
Decision Date
04/07/2003
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
FDA Source Information for K030136
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