Cranial Measurement Software

QQO · Class I — Low Risk (general controls) · General, Plastic Surgery · 21 CFR 878.4800

Classification

FDA Product Code: QQO
Device class: Class I — Low Risk (general controls)
Regulation: 21 CFR 878.4800
Review panel: NE
Medical specialty: General, Plastic Surgery
Submission type: 4
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

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.

Market data

Cleared 510(k) submissions: 1
Registered establishments: 3

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown