510(k) K013234
K013234 is an FDA 510(k) premarket notification submitted by Cane S.R.L. for the device "MICROJET CRONO". The FDA issued a decision of Substantially Equivalent on April 26, 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
- April 26, 2002
- Date Received
- September 27, 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