510(k) K091181

LOCKBOX FOR USE WITH MEDFUSION 3000 SERIES PUMPS by Smiths Medical MD, Inc. — Product Code MRZ

K091181 is an FDA 510(k) premarket notification submitted by Smiths Medical MD, Inc. for the device "LOCKBOX FOR USE WITH MEDFUSION 3000 SERIES PUMPS". The FDA issued a decision of Substantially Equivalent on June 12, 2009. 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
June 12, 2009
Date Received
April 23, 2009
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