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Luna CPAP and Auto CPAP System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K153387

by 3B Medical, Inc.

Identifiers

510(k) Number
K153387 FDA 510(k)
FDA Product Code
BZD FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 868.5905 FDA 510(k)
Regulation Number
868.5905 FDA 510(k)
Advisory Committee
Anesthesiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Luna CPAP and Auto CPAP System is a non-continuous ventilator designed to provide positive airway pressure therapy. It functions by delivering air pressure to assist with breathing patterns.

This device is authorized under FDA 510(k) clearance. It is classified as a class 2 medical device under regulation number 868.5905.

Frequently asked questions

What is the primary function of the Luna CPAP and Auto CPAP System?

This device is a non-continuous ventilator designed to provide positive airway pressure therapy. It functions by delivering air pressure to assist patients with their breathing patterns.

What is the regulatory status of this device?

The Luna CPAP and Auto CPAP System is authorized under FDA 510(k) clearance. It is classified as a class 2 medical device under regulation number 868.5905.

Who is the manufacturer of this system?

The Luna CPAP and Auto CPAP System is manufactured by 3B Medical, Inc., located in Lake Wales, Florida.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: 3B Medical Luna II Auto CPAP Machine with Heated Humidifier, 3B Luna II Auto CPAP Machine Review 2026 | Sleep Foundation, 3B Medical Luna G3 Auto CPAP with Heated Humidifier, 3B Medical Luna II Auto CPAP Machine with Heated Humidifier

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
3B Medical, Inc.

Sources (1)

  • FDA 510(k) K153387 24 fields · synced Sep 27, 2026