510(k) K091042

CRONO S-PID 50 by Cane S.R.L. — Product Code FRN

K091042 is an FDA 510(k) premarket notification submitted by Cane S.R.L. for the device "CRONO S-PID 50". The FDA issued a decision of Substantially Equivalent on May 12, 2009. The device falls under product code FRN (Pump, Infusion), a Class II device regulated under 21 CFR 880.5725. Cane S.R.L. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 12, 2009
Date Received
April 13, 2009
Clearance Type
Special
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