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FDA 510(k) Application Details - K970139
Device Classification Name
Flowmeter, Blood, Cardiovascular
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510(K) Number
K970139
Device Name
Flowmeter, Blood, Cardiovascular
Applicant
MICRO WEISS ELECTRONICS
55 NORTHERN BLVD. SUITE 410
GREAT NECK, NY 11021 US
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Contact
SUSAN D GOLDSTEIN-FALK
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Regulation Number
870.2100
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Classification Product Code
DPW
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More FDA Info for this Product Code
Date Received
01/15/1997
Decision Date
04/30/1998
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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