510(k) K053539
K053539 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corporation for the device "MERIDIAN HEMODIALYSIS MACHINE, MODEL 5M5576". The FDA issued a decision of Substantially Equivalent on May 24, 2006. The device falls under product code KDI (Dialyzer, High Permeability With Or Without Sealed Dialysate System), a Class II device regulated under 21 CFR 876.5860. Baxter Healthcare Corporation has 60 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 24, 2006
- Date Received
- Dec 20, 2005
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Dialyzer, High Permeability With Or Without Sealed Dialysate System
- Device Class
- Class II
- Regulation Number
- 876.5860
- Review Panel
- GU
- Submission Type
- 510(k)