NXSTAGE DIALYSATE PREPARATION MODULE, MODEL NX0269— 510(k) K043436
Substantially EquivalentNxstage Medical, Inc.
FDA 510(k) clearance K043436 for NXSTAGE DIALYSATE PREPARATION MODULE, MODEL NX0269, Substantially Equivalent on 2005-03-17. Applicant: Nxstage Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Nxstage Medical, Inc.
- Product code
- Code FKR
- Device class
- Class 2
- Regulation
- 21 CFR 876.5820
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Lawrence, MA, US
Recent devices under product code FKR
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