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FDA 510(k) Application Details - K183322
Device Classification Name
Electrocardiograph
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510(K) Number
K183322
Device Name
Electrocardiograph
Applicant
physIQ, Inc
300 E. 5th Avenue, Suite 105
Naperville, IL 60563 US
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Contact
George Allen Hides
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Regulation Number
870.2340
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Classification Product Code
DPS
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More FDA Info for this Product Code
Date Received
11/30/2018
Decision Date
07/10/2019
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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