← FDA Medical Device Classifications

Apparatus, Nitric Oxide, Backup Delivery

MRO · Class II — Moderate Risk (510(k) clearance required) · Anesthesiology · 21 CFR 868.5165

Classification

FDA Product Code

MRO

Device class

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

Regulation

21 CFR 868.5165

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

4

Registered establishments

7

Source

Authoritative

FDA Device Classification database

Machine

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