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BTC · Class I — Low Risk (general controls) · Anesthesiology · 21 CFR 868.5320

Classification

FDA Product Code

BTC

Device class

Class I — Low Risk (general controls)

Regulation

21 CFR 868.5320

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

93

Source

Authoritative

FDA Device Classification database

Machine

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