510(k) K931552
K931552 is an FDA 510(k) premarket notification submitted by Davol, Inc. for the device "DAVOL CARDIOVASCULAR AUTOTRANSFUSION UNIT". The FDA issued a decision of Substantially Equivalent on October 8, 1993. The device falls under product code CAC (Apparatus, Autotransfusion), a Class II device regulated under 21 CFR 868.5830. Davol, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 8, 1993
- Date Received
- March 29, 1993
- 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