Product Classification

• Device: sparse sample pk profile and dosing software
• Regulation Description: Predictive pulmonary-function value calculator.
• Definition: To estimate PK profile and dosing calculation.
• Physical State: Solid
• Technical Method: Software driven
• Target Area: Blood
• Regulation Medical Specialty: Anesthesiology
• Review Panel: Hematology
• Product Code: PHY
• Premarket Review: Center for Biologics Evaluation & Research (CBER)
• Submission Type: 510(k)
• Regulation Number: 868.1890
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Eligible
• Implanted Device?: No
• Life-Sustain/Support Device?: No

Third Party Review

Not Third Party Eligible