← FDA Medical Device Classifications

Tester, Electrode/Lead, Electroencephalograph

GYA · Class I — Low Risk (general controls) · Neurology · 21 CFR 882.1410

Classification

FDA Product Code

GYA

Device class

Class I — Low Risk (general controls)

Regulation

21 CFR 882.1410

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

5

Registered establishments

8

Source

Authoritative

FDA Device Classification database

Machine

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