FDA 510(k) Application Details - K970211

Device Classification Name Flowmeter, Blood, Cardiovascular

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510(K) Number K970211
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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Date Received 01/21/1997
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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