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BSI · Class II — Moderate Risk (510(k) clearance required) · Anesthesiology · 21 CFR 868.1040

Classification

FDA Product Code

BSI

Device class

Class II — Moderate Risk (510(k) clearance required)

Regulation

21 CFR 868.1040

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

0

Registered establishments

0

Source

Authoritative

FDA Device Classification database

Machine

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