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FDA 510(k) Application Details - K991545
Device Classification Name
Blood Pressure Cuff
More FDA Info for this Device
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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More FDA Info for this Product Code
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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