Resuscitator, Manual, Non Self-Inflating

NHK · Class II — Moderate Risk (510(k) clearance required) · Anesthesiology · 21 CFR 868.5905

Classification

FDA Product Code: NHK
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 868.5905
Review panel: AN
Medical specialty: Anesthesiology
Submission type: 1
GMP exempt: N
Life sustaining: Y
Implant: N
Third-party review: N

Definition

A non self-inflating manual resuscitator, also called a hyperinflation system, is a manual ventilator intended to ventilate a patient by forcing a volume of fresh gas into the patient via compression of the ventilator bag; a source of compressed breathing gas is required to inflate the bag.

Market data

Cleared 510(k) submissions: 10
Registered establishments: 8

Source

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