FDA 510(k) Application Details - K921343

Device Classification Name Transducer, Blood-Pressure, Extravascular

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510(K) Number K921343
Device Name Transducer, Blood-Pressure, Extravascular
Applicant COBE CARDIOVASCULAR, INC.
14401 WEST 65TH WAY
ARVADA, CO US
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Contact MARY L ARMSTRONG
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Regulation Number 870.2850

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Classification Product Code DRS
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Date Received 03/19/1992
Decision Date 01/05/1993
Decision SE - Substantially Equivalent
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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