OSM-1 OXYGEN SATURATION MONITOR
Device Facts
| Record ID | K853331 |
|---|---|
| Device Name | OSM-1 OXYGEN SATURATION MONITOR |
| Applicant | Criticare Systems, Inc. |
| Product Code | JOM · Cardiovascular |
| Decision Date | Jan 14, 1986 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.2780 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A hydraulic, pneumatic, or photoelectric plethysmograph is a device used to estimate blood flow in a region of the body using hydraulic, pneumatic, or photoelectric measurement techniques.
