R & D SYSTEMS' WHOLE BLOOD FLOW CONTROL, (R & D - WBFC)— 510(k) K961610
Substantially EquivalentR&D Systems, Inc.
FDA 510(k) clearance K961610 for R & D SYSTEMS' WHOLE BLOOD FLOW CONTROL, (R & D - WBFC), Substantially Equivalent on 1996-07-01. Applicant: R&D Systems, Inc..
Clearance details
- Applicant
- R&D Systems, Inc.
- Product code
- Code GKZ
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Minneapolis, MN, US
Adverse events under product code GKZ
product code GKZ- Malfunction
- 1,205
- Total
- 1,205
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.