21 CFR 870.1450 — Densitometer

Cardiovascular (CV) · Part 870 Subpart B—Cardiovascular Diagnostic Devices · § 870.1450

Identification

A densitometer is a device used to measure the transmission of light through an indicator in a sample of blood.

Classification Rationale

Class II (performance standards).

Product Codes

Product CodeDevice NameClassDevicesAttributes
DXMDensitometer223rd Party
Innolitics

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