510(k) K935659
K935659 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "BAXTER NIGHT EXCH DEVICE(NXD) PERITONEAL DIALY SYST". The FDA issued a decision of Substantially Equivalent on Jul 7, 1994. The device falls under product code FKX (System, Peritoneal, Automatic Delivery), a Class II device regulated under 21 CFR 876.5630. Baxter Healthcare Corp has 507 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 7, 1994
- Date Received
- Nov 24, 1993
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- System, Peritoneal, Automatic Delivery
- Device Class
- Class II
- Regulation Number
- 876.5630
- Review Panel
- GU
- Submission Type
- 510(k)