← FDA Medical Device Classifications

Liquid Chemical Processing System

OVY · Class II — Moderate Risk (510(k) clearance required) · General Hospital · 21 CFR 880.6887

Classification

FDA Product Code
OVY
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 880.6887
Review panel
HO
Medical specialty
General Hospital
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N

Definition

The liquid chemical processing system is intended as a standard method for routine monitoring.

Market data

Cleared 510(k) submissions
4
Registered establishments
1

Source

Authoritative
FDA Device Classification database
Machine
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