FDA 510(k) Application Details - K881297

Device Classification Name Transducer, Blood-Pressure, Extravascular

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510(K) Number K881297
Device Name Transducer, Blood-Pressure, Extravascular
Applicant INSTROMEDIX, INC.
ONE TECHNOLOGY CENTER
7431 N.E. EVERGREEN PARKWAY
HILLSBORO, OR US
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Contact SEMLER, M.D.
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Regulation Number 870.2850

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Classification Product Code DRS
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Date Received 03/28/1988
Decision Date 09/16/1988
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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