← FDA Medical Device Classifications

Cleaners, Medical Devices

MDZ · Class II — Moderate Risk (510(k) clearance required) · General Hospital · 21 CFR 880.6992

Classification

FDA Product Code

MDZ

Device class

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

Regulation

21 CFR 880.6992

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

2

Registered establishments

2

Source

Authoritative

FDA Device Classification database

Machine

JSON-LD · Markdown