21 CFR 868.1900 — Calculator, Pulmonary Function Interpretor (Diagnostic)

Anesthesiology (AN) · Part 868 Subpart B—Diagnostic Devices · § 868.1900

Identification

A diagnostic pulmonary-function interpretation calculator is a device that interprets pulmonary study data to determine clinical significance of pulmonary-function values.

Classification Rationale

Class II (performance standards).

Product Codes

Product CodeDevice NameClassDevicesAttributes
BZMCalculator, Pulmonary Function Interpretor (Diagnostic)2263rd Party
PHZAbnormal Breath Sound Device263rd Party
Innolitics

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