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FDA 510(k) Application Details - K920572

Device Classification Name Recorder, Magnetic Tape, Medical

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510(K) Number K920572
Device Name Recorder, Magnetic Tape, Medical
Applicant UNISCAN LTD.
1564 CALLE ORINDA
CAMARILLO, CA US
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Contact JOHN A HUMPHREY
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Regulation Number 870.2800

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Classification Product Code DSH
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Date Received 02/07/1992
Decision Date 04/06/1992
Decision SE - Substantially Equivalent
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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