OSMOMETER MODEL OM-6010
Device Facts
| Record ID | K811179 |
|---|---|
| Device Name | OSMOMETER MODEL OM-6010 |
| Applicant | Fiske Med Science |
| Product Code | JJM · Clinical Chemistry |
| Decision Date | May 15, 1981 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.2730 |
| Device Class | Class 1 |
Regulatory Classification
Identification
An osmometer for clinical use is a device intended to measure the osmotic pressure of body fluids. Osmotic pressure is the pressure required to prevent the passage of a solution with a lesser solute concentration into a solution with greater solute concentration when the two solutions are separated by a semipermeable membrane. The concentration of a solution affects its osmotic pressure, freezing point, and other physiochemical properties. Osmometers determine osmotic pressure by methods such as the measurement of the freezing point. Measurements obtained by this device are used in the diagnosis and treatment of body fluid disorders.
