PUH · Analyzer, Body Composition, Exempt
Cardiovascular · 21 CFR 870.2770 · Class 2
Overview
| Product Code | PUH |
|---|---|
| Device Name | Analyzer, Body Composition, Exempt |
| Regulation | 21 CFR 870.2770 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
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.
Classification Rationale
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.
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.
Recent Cleared Devices (0 of 0)
No cleared devices on record.
