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U.S. Department of Health and Human Services

Product Classification

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Device calculator, drug dose
Regulation Description Predictive pulmonary-function value calculator.
Regulation Medical Specialty Anesthesiology
Review Panel Clinical Chemistry
Product CodeNDC
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
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
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