FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PrismaSATE
K Number: K162887
·
Decision Jan 6, 2017
Classifications
1
FEI Numbers
35
Registration Numbers
35
Same Product Code
122
Applicant Total
61
Review Days
81
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Basic Information
- Device Name
- PrismaSATE
- K Number
- K162887
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 876.5820
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Baxter Healthcare Corporation
- Date Received
- October 17, 2016
- Decision Date
- January 6, 2017
- Product Code
- KPO
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| KPO | Dialysate Concentrate For Hemodialysis (Liquid Or Powder) | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KPO), ordered by most recent decision date.
NaturaLyte® Dry Bicarbonate Concentrate (08-4112-2)
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Bicarby Dialysate RFP-404 (RFP-404-W); Bicarby Dialysate RFP-403 (RFP-403-W); Bicarby Dialysate RFP-403 (RFP-403-G); Bicarby Dialysate RFP-453 (RFP-453-W); Bicarby Dialysate RFP-453 (RFP-453-G); Bicarby Dialysate RFP-454 (RFP-454-W); Bicarby Dialysate RFP-454 (RFP-454-G); Bicarby Dialysate RFP-456 (RFP-456-W)
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