FDA 510(k) Application Details - K990648

Device Classification Name System, Measurement, Blood-Pressure, Non-Invasive

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510(K) Number K990648
Device Name System, Measurement, Blood-Pressure, Non-Invasive
Applicant KELLER MEDICAL SPECIALTIES PRODUCTS, INC.
42609 CRAWFORD RD.
ANTIOCH, IL 60002 US
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Contact JEAN WAGNER
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Regulation Number 870.1130

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Classification Product Code DXN
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Date Received 03/01/1999
Decision Date 08/10/1999
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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