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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name calculator, drug dose
510(k) Number K121542
Device Name PICIS WEIGHT BASED DOSE CONVERTER
Applicant
PICIS INC.
1835 MARKET ST, 29TH FLOOR
PHILADELPHIA,  PA  19103
Applicant Contact JANICE HOGAN
Correspondent
PICIS INC.
1835 MARKET ST, 29TH FLOOR
PHILADELPHIA,  PA  19103
Correspondent Contact JANICE HOGAN
Regulation Number868.1890
Classification Product Code
NDC  
Date Received05/24/2012
Decision Date 08/27/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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