510(k) K082783

CADD -SOLIS MEDICATION SAFETY SOFTWARE: ADMINISTRATOR AND POINT-OF-CARE by Smiths Medical MD, Inc. — Product Code MRZ

K082783 is an FDA 510(k) premarket notification submitted by Smiths Medical MD, Inc. for the device "CADD -SOLIS MEDICATION SAFETY SOFTWARE: ADMINISTRATOR AND POINT-OF-CARE". The FDA issued a decision of Substantially Equivalent on December 17, 2008. The device falls under product code MRZ (Accessories, Pump, Infusion), a Class II device regulated under 21 CFR 880.5725. Smiths Medical MD, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 17, 2008
Date Received
September 23, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accessories, Pump, Infusion
Device Class
Class II
Regulation Number
880.5725
Review Panel
HO
Submission Type