Densitometer
The Densitometer is a cardiovascular diagnostic device used to measure the optical density of blood or indicator solutions, typically to assist in the calculation of cardiac output by analyzing dye-dilution curves. It is classified as FDA Class 2, indicating moderate risk, and must receive 510(k) clearance before it can be marketed. The product code is DXM and the applicable regulation is 21 CFR 870.1450, under the Cardiovascular medical specialty. This device is eligible for third-party 510(k) review.
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Basic Information
- Product Code
- DXM
- Device Class
- FDA class 2
- Regulation Number
- 870.1450
- Medical Specialty
- Cardiovascular
- Review Panel
- CV
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.