Product code QQO

Device name

Cranial Measurement Software

Medical specialty

General, Plastic Surgery

Device class

1

Regulation number

878.4800

Review panel

NE

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

Definition

Cranial measurement software is intended to be used to calculate and display physical measurements of the head for interpretation by a qualified user in conjunction with other clinical methods.

Source

FDA openFDA device classification dataset