← FDA Medical Device Classifications

Gas-Machine, Anesthesia

BSZ · Class II — Moderate Risk (510(k) clearance required) · Anesthesiology · 21 CFR 868.5160

Classification

FDA Product Code
BSZ
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 868.5160
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
187
Registered establishments
32

Source

Authoritative
FDA Device Classification database
Machine
JSON-LD · Markdown