← FDA Medical Device Classifications

Unit, Examining/Treatment, Ent

ETF · Class I — Low Risk (general controls) · Ear, Nose, Throat · 21 CFR 874.5300

Classification

FDA Product Code

ETF

Device class

Class I — Low Risk (general controls)

Regulation

21 CFR 874.5300

Review panel

EN

Medical specialty

Ear, Nose, Throat

Submission type

4

GMP exempt

N

Life sustaining

N

Implant

N

Third-party review

N

Market data

Cleared 510(k) submissions

32

Registered establishments

21

Source

Authoritative

FDA Device Classification database

Machine

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