21 CFR 868.1880 — Calculator, Pulmonary Function Data
Anesthesiology (AN) · Part 868 Subpart B—Diagnostic Devices · § 868.1880
Identification
A pulmonary-function data calculator is a device used to calculate pulmonary-function values based on actual physical data obtained during pulmonary-function testing.
Classification Rationale
Class II (performance standards).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| BZC | Calculator, Pulmonary Function Data | 2 | 90 | 3rd Party |
