← FDA Medical Device Classifications

Meter, Conductivity, Non-Remote

FIZ · Class II — Moderate Risk (510(k) clearance required) · Gastroenterology, Urology · 21 CFR 876.5820

Classification

FDA Product Code

FIZ

Device class

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

Regulation

21 CFR 876.5820

Review panel

GU

Medical specialty

Gastroenterology, Urology

Submission type

1

GMP exempt

N

Life sustaining

Y

Implant

N

Third-party review

N

Market data

Cleared 510(k) submissions

13

Registered establishments

2

Source

Authoritative

FDA Device Classification database

Machine

JSON-LD · Markdown