PSN DIALYZER, MODEL PSN 130/R5M4233, MODEL PSN-150/R5M4234— 510(k) K980658
Substantially EquivalentBaxter Healthcare Corp
FDA 510(k) clearance K980658 for PSN DIALYZER, MODEL PSN 130/R5M4233, MODEL PSN-150/R5M4234, Substantially Equivalent on 1998-05-19. Applicant: Baxter Healthcare Corp. Device class: 2.
Clearance details
- Applicant
- Baxter Healthcare Corp
- Product code
- Code FJI
- Device class
- Class 2
- Regulation
- 21 CFR 876.5820
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mcgaw Park, IL, US
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Adverse events under product code FJI
product code FJI- Death
- 2
- Total
- 2
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.