OLH
- Product code
- OLH
- Device name
- Orchidometer
- Device class
- Class 1
- 21 CFR
- 21 CFR 876.4730
- Medical specialty
- Gastroenterology, Urology
- Marketing pathway
- 510(K) Exempt
FDA classification definition
To measure testicular volume to diagnose abnormalities, or to determine the size of testicular prosthesis to implant.
Official FDA classification page: OLH
Classification and pathway per current FDA publications. Data from openFDA (CC0).