21 CFR 880.5045 — Cleaner, Air, Medical Recirculating

General Hospital (HO) · Part 880 Subpart F—General Hospital and Personal Use Therapeutic Devices · § 880.5045

Identification

A medical recirculating air cleaner is a device used to remove particles from the air for medical purposes. The device may function by electrostatic precipitation or filtration.

Classification Rationale

Class II (performance standards).

Product Codes

Product CodeDevice NameClassDevicesAttributes
FRFCleaner, Air, Medical Recirculating2533rd Party
NUPCream, Nasal, Topical, Mechanical Allergen Particle Barrier28
Innolitics

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