510(k) K940519
K940519 is an FDA 510(k) premarket notification submitted by Dideco for the device "DIDECO COMPACT-A AUTOTRANSFUSION SYSTEM". The FDA issued a decision of Substantially Equivalent on Jan 19, 1995. The device falls under product code CAC (Apparatus, Autotransfusion), a Class II device regulated under 21 CFR 868.5830. Dideco has 32 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 19, 1995
- Date Received
- Feb 4, 1994
- Clearance Type
- Traditional
- 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)