510(k) K812355
K812355 is an FDA 510(k) premarket notification submitted by Intl. Business Machines for the device "IBM 2991 BLOOD CELL PROCESSOR MOD. 1 & 2". The FDA issued a decision of Substantially Equivalent on September 9, 1981. The device falls under product code CAC (Apparatus, Autotransfusion), a Class II device regulated under 21 CFR 868.5830. Intl. Business Machines has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 9, 1981
- Date Received
- August 19, 1981
- 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