FDA 510(k)

Breathe+

K-Number: K222018 · 2023-06-02

ApplicantPeep Medical, LLC Dba Go2 Devices

Decision Date2023-06-02

Product CodeBWF

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

Breathe+ is the device name listed in this FDA 510(k) record. The listed applicant is Peep Medical, LLC Dba Go2 Devices. It received FDA 510(k) clearance on 2023-06-02 under 510(k) number K222018. The device is classified under product code BWF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Breathe+?

Breathe+ is a medical device that received FDA 510(k) clearance on 2023-06-02. The listed applicant is Peep Medical, LLC Dba Go2 Devices. The 510(k) number is K222018.

When did Breathe+ receive FDA 510(k) clearance?

Breathe+ received FDA 510(k) clearance on 2023-06-02, under 510(k) number K222018.

Who is the listed applicant for Breathe+?

The FDA 510(k) record lists Peep Medical, LLC Dba Go2 Devices as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Breathe+?

The FDA product code for Breathe+ is BWF.

Related Devices (Code: BWF)

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.

K241152InSeeTidal Medical Technologies, LLC K233855AllPEPEnchant Tek Co. , Ltd.K221058LungTrainer (MD2 & MD3)Lung Trainers, LLC K220565Hudson RCI Triflo II Incentive Deep Breathing ExerciserMedline Industries, Inc.K203378PulsehalerRespinova, Ltd.K192000D R Burton OxyPAPD R Burton Healthcare, LLC

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.