← FDA Medical Device Classifications

Set, I.V. Fluid Transfer

LHI · Class II — Moderate Risk (510(k) clearance required) · General Hospital · 21 CFR 880.5440

Classification

FDA Product Code

LHI

Device class

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

Regulation

21 CFR 880.5440

Review panel

HO

Medical specialty

General Hospital

Submission type

1

GMP exempt

N

Life sustaining

N

Implant

N

Third-party review

Y

Market data

Cleared 510(k) submissions

204

Registered establishments

176

Source

Authoritative

FDA Device Classification database

Machine

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