510(k) K020647

DIDECO ELECTA by Dideco S.P.A. — Product Code CAC

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)

Source: FDA 510(k) database entry for K020647. Report a data issue: hello@regdatalab.com.