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CAH · Class II — Moderate Risk (510(k) clearance required) · Anesthesiology · 21 CFR 868.5260

Classification

FDA Product Code
CAH
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 868.5260
Review panel
HO
Medical specialty
Anesthesiology
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
Y

Market data

Cleared 510(k) submissions
201
Registered establishments
138

Source

Authoritative
FDA Device Classification database
Machine
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