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FDA 510(k)

Luna® G3 BPAP 25A

K-Number: K201620 · 2021-01-29

Applicant3B Medical, Inc.
Decision Date2021-01-29
Product CodeBZD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Luna® G3 BPAP 25A is a medical device manufactured by 3B Medical, Inc.. It received FDA 510(k) clearance on 2021-01-29 under approval number K201620. 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 25A?

Luna® G3 BPAP 25A is a medical device that received FDA 510(k) clearance on 2021-01-29. It is manufactured by 3B Medical, Inc.. The 510(k) number is K201620.

When was Luna® G3 BPAP 25A approved by the FDA?

Luna® G3 BPAP 25A received FDA 510(k) clearance on 2021-01-29, under approval number K201620.

What company makes Luna® G3 BPAP 25A?

Luna® G3 BPAP 25A is manufactured by 3B Medical, Inc..

What is the FDA product code for Luna® G3 BPAP 25A?

The FDA product code for Luna® G3 BPAP 25A is BZD.

Other Devices by 3B Medical, Inc.

K160127iCodeConnect K153387Luna CPAP and Auto CPAP System K200496Aer X K212263Luna G3 BPAP System

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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