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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 the device name listed in this FDA 510(k) record. The listed applicant is 3B Medical, Inc.. It received FDA 510(k) clearance on 2021-01-29 under 510(k) 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. The listed applicant is 3B Medical, Inc.. The 510(k) number is K201620.

When did Luna® G3 BPAP 25A receive FDA 510(k) clearance?

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

Who is the listed applicant for Luna® G3 BPAP 25A?

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 25A?

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

K212263Luna G3 BPAP SystemK200496Aer 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

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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