K-number	K251615
Device name	Aerogen Pro-X1 Controller System
Applicant	Aerogen, Ltd.
Product code	SFP
Device class	Class II
Decision date	Sep 2, 2025
Decision	Substantially Equivalent
Regulation	868.5630

AI Summary extracted from FDA summary PDF · never regenerated

Intended use

The Aerogen Pro-X1 Controller System is a portable medical device that aerosolizes prescribed medications for inhalation in pediatric patients (29 days and older) and adults. It is used in hospital environments for patients undergoing invasive ventilation, non-invasive respiratory support, or who are conscious and spontaneously breathing.

Technological characteristics

Not stated in this summary.

Test standards cited

Not stated in this summary.

Substantial equivalence argument

Not stated in this summary.

Extracted by AI from the official FDA summary PDF →

Source

View the full FDA submission: accessdata.fda.gov

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Aerogen Pro-X1 Controller System

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