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FDA 510(k) Application Details - K181089
Device Classification Name
Cable, Transducer And Electrode, Patient, (Including Connector)
More FDA Info for this Device
510(K) Number
K181089
Device Name
Cable, Transducer And Electrode, Patient, (Including Connector)
Applicant
Authentic Medical
4470 Yankee Hill Rd., Ste 100
Rocklin, CA 95677 US
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Contact
Ricky Souza
Other 510(k) Applications for this Contact
Regulation Number
870.2900
More FDA Info for this Regulation Number
Classification Product Code
DSA
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More FDA Info for this Product Code
Date Received
04/25/2018
Decision Date
01/17/2020
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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