ALTRA FLUX 200 HEMODIALYZER— 510(k) K970679
Substantially EquivalentAlthin Medical AB an Affiliate of Baxter Intl
FDA 510(k) clearance K970679 for ALTRA FLUX 200 HEMODIALYZER, Substantially Equivalent on 1998-07-23. Applicant: Althin Medical AB an Affiliate of Baxter Intl. Device class: 2.
Clearance details
- Applicant
- Althin Medical AB an Affiliate of Baxter Intl
- Product code
- Code MSF
- Device class
- Class 2
- Regulation
- 21 CFR 876.5860
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Miami Lakes, FL, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.