510(k) K013840

MICROJET CRONO PAR AND CRONO APO-GO by Cane S.R.L. — Product Code FRN

K013840 is an FDA 510(k) premarket notification submitted by Cane S.R.L. for the device "MICROJET CRONO PAR AND CRONO APO-GO". The FDA issued a decision of Substantially Equivalent on May 14, 2002. 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 14, 2002
Date Received
November 19, 2001
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