Submission Details
| 510(k) Number | K982650 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 30, 1998 |
| Decision Date | December 16, 1998 |
| Days to Decision | 139 days |
| Submission Type | Abbreviated |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
Cleared
Abbreviated
AUTOLOGOUS BLOOD MANAGEMENT SYSTEM (ABMS)
Dec 1998
Decision
139d
Days
Class 2
Risk
About This 510(k) Submission
K982650 is an FDA 510(k) clearance for the AUTOLOGOUS BLOOD MANAGEMENT SYSTEM (ABMS), 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 December 16, 1998, 139 days after receiving the submission on July 30, 1998. 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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