510(k) K020647
K020647 is an FDA 510(k) premarket notification submitted by Dideco S.P.A. for the device "DIDECO ELECTA". The FDA issued a decision of Substantially Equivalent on Sep 5, 2002. The device falls under product code CAC (Apparatus, Autotransfusion), a Class II device regulated under 21 CFR 868.5830. Dideco S.P.A. has 32 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 5, 2002
- Date Received
- Feb 28, 2002
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Apparatus, Autotransfusion
- Device Class
- Class II
- Regulation Number
- 868.5830
- Review Panel
- CV
- Submission Type
- 510(k)