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FDA 510(k)

Luna G3 BPAP System

K-Number: K212263 · 2022-03-25

Applicant3B Medical, Inc.
Decision Date2022-03-25
Product CodeBZD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Luna G3 BPAP System is a medical device manufactured by 3B Medical, Inc.. It received FDA 510(k) clearance on 2022-03-25 under approval number K212263. The device is classified under product code BZD. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Luna G3 BPAP System?

Luna G3 BPAP System is a medical device that received FDA 510(k) clearance on 2022-03-25. It is manufactured by 3B Medical, Inc.. The 510(k) number is K212263.

When was Luna G3 BPAP System approved by the FDA?

Luna G3 BPAP System received FDA 510(k) clearance on 2022-03-25, under approval number K212263.

What company makes Luna G3 BPAP System?

Luna G3 BPAP System is manufactured by 3B Medical, Inc..

What is the FDA product code for Luna G3 BPAP System?

The FDA product code for Luna G3 BPAP System is BZD.

Other Devices by 3B Medical, Inc.

K160127iCodeConnect K153387Luna CPAP and Auto CPAP System K200496Aer X K201620Luna® G3 BPAP 25A

Related Devices (Code: BZD)

K160836Menai SystemResmed, Ltd. K161978AirFit N20Resmed, Ltd. K160127iCodeConnect3B Medical, Inc. K153505F&P Eson 2 Nasal MaskFisher & Paykel Healthcare Limited K160822S9 VPAP Adapt, VPAP Adapt, AirCurve 10 ASVResmed, Ltd. K153387Luna CPAP and Auto CPAP System3B Medical, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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