TRIEX-IH DIALYZER— 510(k) K822738
Substantially EquivalentExtracorporeal Medical Specialities, Inc.
FDA 510(k) clearance K822738 for TRIEX-IH DIALYZER, Substantially Equivalent on 1982-09-24. Applicant: Extracorporeal Medical Specialities, Inc.. Device class: 2.
Clearance details
- Applicant
- Extracorporeal Medical Specialities, Inc.
- Product code
- Code KOC
- Device class
- Class 2
- Regulation
- 21 CFR 876.5820
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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More clearances from Extracorporeal Medical Specialities, Inc.
view allAdverse events under product code KOC
product code KOC- Death
- 4
- Total
- 4
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.