FDA 510(k) Application Details - K874313

Device Classification Name Recorder, Magnetic Tape, Medical

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510(K) Number K874313
Device Name Recorder, Magnetic Tape, Medical
Applicant DEL MAR AVIONICS
1621 ALTON PKWY.
IRVINE, CA US
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Contact DAVE JOHNSON
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Regulation Number 870.2800

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Classification Product Code DSH
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Date Received 10/20/1987
Decision Date 02/22/1988
Decision SE - Substantially Equivalent
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status
Type Traditional
Reviewed By Third Party N
Expedited Review



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