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FDA 510(k) Application Details - K103637
Device Classification Name
Blood Pressure Cuff
More FDA Info for this Device
510(K) Number
K103637
Device Name
Blood Pressure Cuff
Applicant
ERKA KALLMEYER MEDIZINTECHNIK GMBH
IM FARCHET 15
BAD TOELZ, BAVARIA 83646 DE
Other 510(k) Applications for this Company
Contact
JAN WEISS
Other 510(k) Applications for this Contact
Regulation Number
870.1120
More FDA Info for this Regulation Number
Classification Product Code
DXQ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/13/2010
Decision Date
06/08/2011
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
Y
Expedited Review
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