← FDA Medical Device Classifications

Mask, Oxygen, Low Concentration, Venturi

BYF · Class I — Low Risk (general controls) · Anesthesiology · 21 CFR 868.5600

Classification

FDA Product Code

BYF

Device class

Class I — Low Risk (general controls)

Regulation

21 CFR 868.5600

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

19

Registered establishments

95

Source

Authoritative

FDA Device Classification database

Machine

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