Is the Oto FDA Approved?

The Oto’s status as a Class 1 device exempts it from FDA approval or clearance (Source: 21 CFR Parts 862-892) due to the low-risk level associated with this type of device. CellScope adheres to the FDA’s rules and requirements for marketing, including but not limited to: registration, labeling and good manufacturing practices. More information can be found on the FDA’s website.

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