510(k) K944767
K944767 is an FDA 510(k) premarket notification submitted by Fresenius USA, Inc. for the device "DIALYSIS MACHINE WITH DIALYSATE ULTRAFILTER". The FDA issued a decision of Substantially Equivalent on Nov 29, 1995. The device falls under product code FIP (Subsystem, Water Purification), a Class II device regulated under 21 CFR 876.5665. Fresenius USA, Inc. has 37 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Nov 29, 1995
- Date Received
- Sep 27, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Subsystem, Water Purification
- Device Class
- Class II
- Regulation Number
- 876.5665
- Review Panel
- GU
- Submission Type
- 510(k)