Submission Details
| 510(k) Number | K020647 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 28, 2002 |
| Decision Date | September 05, 2002 |
| Days to Decision | 189 days |
| Submission Type | Abbreviated |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
Cleared
Abbreviated
DIDECO ELECTA
Sep 2002
Decision
189d
Days
Class 2
Risk
About This 510(k) Submission
K020647 is an FDA 510(k) clearance for the DIDECO ELECTA, a Apparatus, Autotransfusion (Class II — Special Controls, product code CAC), submitted by Dideco S.P.A. (North Attleboro, US). The FDA issued a Cleared decision on September 5, 2002, 189 days after receiving the submission on February 28, 2002. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5830.
Device Classification
| Product Code | CAC — Apparatus, Autotransfusion |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 868.5830 |
Manufacturer
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