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 a medical device manufactured by Peep Medical, LLC Dba Go2 Devices. It received FDA 510(k) clearance on 2023-06-02 under approval 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. It is manufactured by Peep Medical, LLC Dba Go2 Devices. The 510(k) number is K222018.
When was Breathe+ approved by the FDA?
Breathe+ received FDA 510(k) clearance on 2023-06-02, under approval number K222018.
What company makes Breathe+?
Breathe+ is manufactured by Peep Medical, LLC Dba Go2 Devices.
What is the FDA product code for Breathe+?
The FDA product code for Breathe+ is BWF.
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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.