TRANSONIC HEMODIALYSIS FLOW REVERSER, MODEL B FLOWREV— 510(k) K002816
Substantially EquivalentTransonic Systems, Inc.
FDA 510(k) clearance K002816 for TRANSONIC HEMODIALYSIS FLOW REVERSER, MODEL B FLOWREV, Substantially Equivalent on 2000-11-22. Applicant: Transonic Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Transonic Systems, 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
- Ithaca, NY, US
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More clearances from Transonic Systems, 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.