510(k) K120209

PATIENT CONTROLLED ANALGESIA (PCA) BUTTON CABLE by American I.V. Products, Inc. — Product Code MRZ

K120209 is an FDA 510(k) premarket notification submitted by American I.V. Products, Inc. for the device "PATIENT CONTROLLED ANALGESIA (PCA) BUTTON CABLE". The FDA issued a decision of Substantially Equivalent on April 12, 2012. The device falls under product code MRZ (Accessories, Pump, Infusion), a Class II device regulated under 21 CFR 880.5725. American I.V. Products, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 12, 2012
Date Received
January 24, 2012
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