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Device, Sleep Assessment

LEL · Class II — Moderate Risk (510(k) clearance required) · Neurology · 21 CFR 882.5050

Classification

FDA Product Code

LEL

Device class

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

Regulation

21 CFR 882.5050

Review panel

NE

Medical specialty

Neurology

Submission type

1

GMP exempt

N

Life sustaining

N

Implant

N

Third-party review

N

Market data

Cleared 510(k) submissions

19

Registered establishments

15

Source

Authoritative

FDA Device Classification database

Machine

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