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FDA 510(k) Application Details - K121542
Device Classification Name
Calculator, Drug Dose
More FDA Info for this Device
510(K) Number
K121542
Device Name
Calculator, Drug Dose
Applicant
PICIS INC.
1835 MARKET ST, 29TH FLOOR
PHILADELPHIA, PA 19103 US
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Contact
JANICE HOGAN
Other 510(k) Applications for this Contact
Regulation Number
868.1890
More FDA Info for this Regulation Number
Classification Product Code
NDC
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More FDA Info for this Product Code
Date Received
05/24/2012
Decision Date
08/27/2012
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
AN - Anesthesiology
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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