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JAY · Class I — Low Risk (general controls) · Anesthesiology · 21 CFR 868.5280

Classification

FDA Product Code

JAY

Device class

Class I — Low Risk (general controls)

Regulation

21 CFR 868.5280

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

69

Source

Authoritative

FDA Device Classification database

Machine

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