← FDA Medical Device Classifications

Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)

CBI · Class II — Moderate Risk (510(k) clearance required) · Anesthesiology · 21 CFR 868.5740

Classification

FDA Product Code

CBI

Device class

Class II — Moderate Risk (510(k) clearance required)

Regulation

21 CFR 868.5740

Review panel

AN

Medical specialty

Anesthesiology

Submission type

1

GMP exempt

N

Life sustaining

Y

Implant

N

Third-party review

N

Market data

Cleared 510(k) submissions

34

Registered establishments

35

Source

Authoritative

FDA Device Classification database

Machine

JSON-LD · Markdown