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HBO · Class II — Moderate Risk (510(k) clearance required) · Neurology · 21 CFR 882.4150

Classification

FDA Product Code

HBO

Device class

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

Regulation

21 CFR 882.4150

Review panel

NE

Medical specialty

Neurology

Submission type

1

GMP exempt

N

Life sustaining

N

Implant

N

Third-party review

Y

Market data

Cleared 510(k) submissions

10

Registered establishments

32

Source

Authoritative

FDA Device Classification database

Machine

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