DXM · Densitometer
Cardiovascular · 21 CFR 870.1450 · Class 2
Overview
| Product Code | DXM |
|---|---|
| Device Name | Densitometer |
| Regulation | 21 CFR 870.1450 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
| 3rd-Party Reviewable | Yes |
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).
Recent Cleared Devices (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K791892 | TAPE-A-TRACE | Instromedix, Inc. | Nov 5, 1979 | SESE |
| K781692 | CALIBRATOR, DYNAMIC | Waters Assoc., Inc. | Nov 29, 1978 | SESE |
Top Applicants
- Instromedix, Inc. — 1 clearance
- Waters Assoc., Inc. — 1 clearance
