21 CFR 868.1840 — Spirometer, Diagnostic
Anesthesiology (AN) · Part 868 Subpart B—Diagnostic Devices · § 868.1840
Identification
A diagnostic spirometer is a device used in pulmonary function testing to measure the volume of gas moving in or out of a patient's lungs.
Classification Rationale
Class II (performance standards).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| BZG | Spirometer, Diagnostic | 2 | 228 | 3rd Party |
| PNV | Impedance Measuring Device Utilizing Oscillation Techniques | 2 | 4 |
