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 Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| DXM | Densitometer | 2 | 2 | 3rd Party |