← FDA Medical Device Classifications

Sterilizers, Non-Medical

RBO · Not classified · Unknown

Classification

FDA Product Code
RBO
Device class
Not classified
Regulation
—
Review panel
—
Medical specialty
Unknown
Submission type
—
GMP exempt
Y
Life sustaining
—
Implant
—
Third-party review
—

Definition

A linear accelerator used as a sterilizer for non-medical instruments and applications.

Market data

Cleared 510(k) submissions
0
Registered establishments
0

Source

Authoritative
FDA Device Classification database
Machine
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