MODIFICATION TO BIOZ.COM HEMODYNAMIC MONITOR
Device Facts
| Record ID | K011439 |
|---|---|
| Device Name | MODIFICATION TO BIOZ.COM HEMODYNAMIC MONITOR |
| Applicant | Cardiodynamics International Corp. |
| Product Code | DSB · Cardiovascular |
| Decision Date | Nov 2, 2001 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.2770 |
| Device Class | Class 2 |
Regulatory Classification
Identification
An impedance plethysmograph is a device used to estimate peripheral blood flow by measuring electrical impedance changes in a region of the body such as the arms and legs.
Special Controls
*Classification.* Class II (special controls). The device, when it is a body composition analyzer which is not intended to diagnose or treat any medical condition, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
