← FDA Medical Device Classifications

Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)

CBR · Class II — Moderate Risk (510(k) clearance required) · Anesthesiology · 21 CFR 868.1700

Classification

FDA Product Code
CBR
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 868.1700
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
5
Registered establishments
55

Source

Authoritative
FDA Device Classification database
Machine
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