← FDA Medical Device Classifications

Humidifier, Non-Direct Patient Interface (Home-Use)

KFZ · Class I — Low Risk (general controls) · Anesthesiology · 21 CFR 868.5460

Classification

FDA Product Code

KFZ

Device class

Class I — Low Risk (general controls)

Regulation

21 CFR 868.5460

Review panel

AN

Medical specialty

Anesthesiology

Submission type

4

GMP exempt

N

Life sustaining

N

Implant

N

Third-party review

N

Market data

Cleared 510(k) submissions

20

Registered establishments

114

Source

Authoritative

FDA Device Classification database

Machine

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