Infusion Safety Management Software

PHC · Class II — Moderate Risk (510(k) clearance required) · General Hospital · 21 CFR 880.5725

Classification

FDA Product Code: PHC
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 880.5725
Review panel: HO
Medical specialty: General Hospital
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

Definition

Infusion safety management software is a prescription device intended for use with infusion pumps and may include one or more of the following capabilities: prepopulation of infusion programming parameters, data retrieval and analysis for tracking and trending, drug infusion error reduction algorithms, and alarm transmission.

Market data

Cleared 510(k) submissions: 10
Registered establishments: 28

Source

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