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FDA 510(k) Application Details - K131190
Device Classification Name
Recorder, Magnetic Tape, Medical
More FDA Info for this Device
510(K) Number
K131190
Device Name
Recorder, Magnetic Tape, Medical
Applicant
DMS-SERVICE LLC
2800 NEILSON WAY, STE. 1
SANTA MONICA, CA 90405 US
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Contact
LYNDA S COLE
Other 510(k) Applications for this Contact
Regulation Number
870.2800
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Classification Product Code
DSH
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More FDA Info for this Product Code
Date Received
04/26/2013
Decision Date
10/29/2013
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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