510(k) K901038
K901038 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "SPS 550-IPS (INTEGRATED PATIENT STATION)". The FDA issued a decision of Substantially Equivalent on Apr 19, 1990. The device falls under product code FIL (System, Dialysate Delivery, Single Pass), a Class II device regulated under 21 CFR 876.5820. Baxter Healthcare Corp has 507 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 19, 1990
- Date Received
- Mar 6, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- System, Dialysate Delivery, Single Pass
- Device Class
- Class II
- Regulation Number
- 876.5820
- Review Panel
- GU
- Submission Type
- 510(k)