← FDA Medical Device Classifications

Monitor, Apnea, Facility Use

FLS · Class II — Moderate Risk (510(k) clearance required) · Anesthesiology · 21 CFR 868.2377

Classification

FDA Product Code

FLS

Device class

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

Regulation

21 CFR 868.2377

Review panel

AN

Medical specialty

Anesthesiology

Submission type

1

GMP exempt

N

Life sustaining

Y

Implant

N

Third-party review

N

Market data

Cleared 510(k) submissions

16

Registered establishments

3

Source

Authoritative

FDA Device Classification database

Machine

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