510(k) K864179
K864179 is an FDA 510(k) premarket notification submitted by Ash Medical Systems, Inc. for the device "BIOLOGIC 1000 HEMODIALYSIS MACH/HD-1000 DISP CARTR". The FDA issued a decision of Substantially Equivalent on Dec 11, 1986. The device falls under product code FKT (System, Dialysate Delivery, Sorbent Regenerated), a Class II device regulated under 21 CFR 876.5600. Ash Medical Systems, Inc. has 2 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 11, 1986
- Date Received
- Oct 24, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- System, Dialysate Delivery, Sorbent Regenerated
- Device Class
- Class II
- Regulation Number
- 876.5600
- Review Panel
- GU
- Submission Type
- 510(k)