FDA 510(k) Application Details - K030136

Device Classification Name Monitor, Electric For Gravity Flow Infusion Systems

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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
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Regulation Number 880.2420

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Classification Product Code FLN
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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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