← FDA Medical Device Classifications

Respiratory Accessory Microbial Reduction Device.

QXQ · Class II — Moderate Risk (510(k) clearance required) · General Hospital · 21 CFR 880.6993

Classification

FDA Product Code
QXQ
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 880.6993
Review panel
HO
Medical specialty
General Hospital
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N

Definition

A respiratory accessory microbial reduction device is a home-use device intended to be used as an adjunct for microbial reduction of compatible respiratory accessories,such as hoses and masks,after cleaning. This device is not intended to replace the original accessory manufacturer’s cleaning instructions.

Market data

Cleared 510(k) submissions
3
Registered establishments
2

Source

Authoritative
FDA Device Classification database
Machine
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