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HBR · Class I — Low Risk (general controls) · Neurology · 21 CFR 882.4215

Classification

FDA Product Code

HBR

Device class

Class I — Low Risk (general controls)

Regulation

21 CFR 882.4215

Review panel

NE

Medical specialty

Neurology

Submission type

4

GMP exempt

N

Life sustaining

N

Implant

N

Third-party review

N

Market data

Cleared 510(k) submissions

1

Registered establishments

15

Source

Authoritative

FDA Device Classification database

Machine

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