Product code SBI

Device name

Manual Refractor, 3d Display

Medical specialty

Ophthalmic

Device class

1

Regulation number

886.1770

Review panel

OP

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

Definition

A 3D Display Manual Refractor is an optical device intended to measure the refractive error of the eye.

Source

FDA openFDA device classification dataset