510(k) K052218

CRONO FIVE AND CRONO PCA 50 by Cane S.R.L. — Product Code FRN

K052218 is an FDA 510(k) premarket notification submitted by Cane S.R.L. for the device "CRONO FIVE AND CRONO PCA 50". The FDA issued a decision of Substantially Equivalent on November 23, 2005. 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
November 23, 2005
Date Received
August 15, 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