510(k) K041414

CRONO AND CRONO, MODEL 30 by Cane S.R.L. — Product Code FRN

K041414 is an FDA 510(k) premarket notification submitted by Cane S.R.L. for the device "CRONO AND CRONO, MODEL 30". The FDA issued a decision of Substantially Equivalent on July 8, 2004. 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
July 8, 2004
Date Received
May 27, 2004
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