← FDA Medical Device Classifications

Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph

CHL · Class II — Moderate Risk (510(k) clearance required) · Clinical Chemistry · 21 CFR 862.1120

Classification

FDA Product Code

CHL

Device class

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

Regulation

21 CFR 862.1120

Review panel

CH

Medical specialty

Clinical Chemistry

Submission type

1

GMP exempt

N

Life sustaining

N

Implant

N

Third-party review

Y

Market data

Cleared 510(k) submissions

188

Registered establishments

34

Source

Authoritative

FDA Device Classification database

Machine

JSON-LD · Markdown