21 CFR 868.1860 — Meter, Peak Flow, Spirometry
Anesthesiology (AN) · Part 868 Subpart B—Diagnostic Devices · § 868.1860
Identification
A peak-flow meter for spirometry is a device used to measure a patient's maximum ventilatory flow rate.
Classification Rationale
Class II (performance standards).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| BZH | Meter, Peak Flow, Spirometry | 2 | 79 | 3rd Party |