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FDA 510(k) Application Details - K173461
Device Classification Name
Recorder, Magnetic Tape, Medical
More FDA Info for this Device
510(K) Number
K173461
Device Name
Recorder, Magnetic Tape, Medical
Applicant
Smart Solutions Technologies SL
Calle Toronga 21, Local 1
Madrid 28015 ES
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Contact
Daniel Llorca
Other 510(k) Applications for this Contact
Regulation Number
870.2800
More FDA Info for this Regulation Number
Classification Product Code
DSH
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More FDA Info for this Product Code
Date Received
11/07/2017
Decision Date
08/03/2018
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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