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 CodeDevice NameClassDevicesAttributes
BZHMeter, Peak Flow, Spirometry2793rd Party
Innolitics

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