{
  "id": "https://uofa.net/morrison/decision/cou1-overall",
  "type": "DecisionRecord",
  "actor": "https://uofa.net/org/FDA-CDRH",
  "role": "Credibility assessment team",
  "outcome": "Accepted",
  "rationale": "Model deemed sufficiently credible for COU1. All verification goals achieved at or above target gradation levels. Validation comparison at all 5 operating conditions shows hemolysis index below CPB predicate threshold (RH < 1). No formal CFD uncertainty quantification performed for COU1 (addressed by W-AL-01 weakener).",
  "decidedAt": "2019-02-01T00:00:00Z"
}