FDA 510(k) Application Details - K990266

Device Classification Name System, Ecg Analysis

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510(K) Number K990266
Device Name System, Ecg Analysis
Applicant MICROMEDICAL INDUSTRIES, LTD.
189 HAPP RD.
NORTHFIELD, IL 60093 US
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Contact DEAN E SYNDER
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Regulation Number 000.0000

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Classification Product Code LOS
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Date Received 01/28/1999
Decision Date 02/02/1999
Decision SESE - SUBST EQUIV
Classification Advisory Committee -
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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