21 CFR 868.1890 — Calculator, Predicted Values, Pulmonary Function
Anesthesiology (AN) · Part 868 Subpart B—Diagnostic Devices · § 868.1890
Identification
A predictive pulmonary-function value calculator is a device used to calculate normal pulmonary-function values based on empirical equations.
Classification Rationale
Class II (performance standards).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| BTY | Calculator, Predicted Values, Pulmonary Function | 2 | 63 | 3rd Party |
| NDC | Calculator, Drug Dose | 2 | 53 | |
| PDT | Burn Resuscitation Decision Support Software | 2 | 2 | SaMD, 3rd Party |
| PHY | Sparse Sample Pk Profile And Dosing Software | 2 | 0 |
