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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 the device name listed in this FDA 510(k) record. The listed applicant is 3B Medical, Inc.. It received FDA 510(k) clearance on 2022-03-25 under 510(k) 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. The listed applicant is 3B Medical, Inc.. The 510(k) number is K212263.

When did Luna G3 BPAP System receive FDA 510(k) clearance?

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

Who is the listed applicant for Luna G3 BPAP System?

The FDA 510(k) record lists 3B Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing 3B Medical, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K201620Luna® G3 BPAP 25AK200496Aer XK160127iCodeConnectK153387Luna CPAP and Auto CPAP System

Related Devices (Code: BZD)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253044RXiBreeze PAP System (RXiBreeze 20C)Resvent Medical Technology Co., Ltd.K253553OrionResmed CorpK254104ResScan EssentialsResmed CorpK251920Sleep Apnea Breathing Therapy Mask:JoyMask 20-B Full Face Mask, JoyMask 21-B Full Face MaskDcstar, Inc.K253166F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S)BMC Medical Co., Ltd.K252338MySleepDashSomnetics International, Inc. (Dba Transcend Inc)

Official Source

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

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