FDA 510(k) Application Details - K991545

Device Classification Name Blood Pressure Cuff

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510(K) Number K991545
Device Name Blood Pressure Cuff
Applicant INDUSTRIELLE ENTWICKLUNG MEDIZINTECHNIK UND VERTRI
11641 RED HIBISCUS DR.
BONITA SPRINGS, FL 34135 US
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Contact GUENTER GINSBERG
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Regulation Number 870.1120

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Classification Product Code DXQ
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Date Received 05/03/1999
Decision Date 01/19/2000
Decision SESE - SUBST EQUIV
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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