21 CFR 868.5925 — Ventilator, Emergency, Powered (Resuscitator)

Anesthesiology (AN) · Part 868 Subpart F—Therapeutic Devices · § 868.5925

Identification

A powered emergency ventilator is a demand valve or inhalator intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient's airway.

Classification Rationale

Class II (performance standards).

Product Codes

Product CodeDevice NameClassDevicesAttributes
BTLVentilator, Emergency, Powered (Resuscitator)2100Life-Sustaining
Innolitics

Panel 1

/
Ready

Predicate graph will load when search results are available.

Embedding visualization will load when search results are available.

PDF viewer will load when search results are available.

Loading panels...

Select an item from Submissions

Click any panel, subpart, regulation, product code, or device to see details here.

Section Matches

Results will appear here.

Product Code Matches

Results will appear here.

Special Control Matches

Results will appear here.

Loading collections...