Continuous Glucose Monitor Retrospective Data Analysis Software

PHV · Class I — Low Risk (general controls) · Clinical Chemistry · 21 CFR 862.2120

Classification

FDA Product Code: PHV
Device class: Class I — Low Risk (general controls)
Regulation: 21 CFR 862.2120
Review panel: CH
Medical specialty: Clinical Chemistry
Submission type: 4
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

Definition

Continuous glucose monitor retrospective data analysis software is intended to analyze and correlate retrospective data from a continuous glucose monitoring device.

Market data

Cleared 510(k) submissions: 1
Registered establishments: 14

Source

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