← FDA Medical Device Classifications

Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)

CBQ · Class II — Moderate Risk (510(k) clearance required) · Anesthesiology · 21 CFR 868.1500

Classification

FDA Product Code

CBQ

Device class

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

Regulation

21 CFR 868.1500

Review panel

AN

Medical specialty

Anesthesiology

Submission type

1

GMP exempt

N

Life sustaining

N

Implant

N

Third-party review

Y

Market data

Cleared 510(k) submissions

22

Registered establishments

54

Source

Authoritative

FDA Device Classification database

Machine

JSON-LD · Markdown