510(k) K051568

CADD-MS 3 AMBULATORY INFUSION PUMP by Smiths Medical MD, Inc. — Product Code FRN

K051568 is an FDA 510(k) premarket notification submitted by Smiths Medical MD, Inc. for the device "CADD-MS 3 AMBULATORY INFUSION PUMP". The FDA issued a decision of Substantially Equivalent on November 17, 2005. The device falls under product code FRN (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
November 17, 2005
Date Received
June 14, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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