510(k) K760856
K760856 is an FDA 510(k) premarket notification submitted by Intl. Business Machines for the device "BLOOD CELL PROCESSOR MODEL 2 IBM 2991". The FDA issued a decision of Substantially Equivalent on January 10, 1977. The device falls under product code GKT (Separator, Automated, Blood Cell, Diagnostic), a Class II device regulated under 21 CFR 864.9245. Intl. Business Machines has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 10, 1977
- Date Received
- October 15, 1976
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Separator, Automated, Blood Cell, Diagnostic
- Device Class
- Class II
- Regulation Number
- 864.9245
- Review Panel
- HE
- Submission Type