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510(k) K222018

Breathe+ by Peep Medical, LLC Dba Go2 Devices — Product Code BWF

K222018 is an FDA 510(k) premarket notification submitted by Peep Medical, LLC Dba Go2 Devices for the device "Breathe+". The FDA issued a decision of Substantially Equivalent on June 2, 2023. The device falls under product code BWF (Spirometer, Therapeutic (Incentive)), a Class II device regulated under 21 CFR 868.5690.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 2, 2023
Date Received
July 8, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Spirometer, Therapeutic (Incentive)
Device Class
Class II
Regulation Number
868.5690
Review Panel
AN
Submission Type

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  • K221058 — LungTrainer (MD2 & MD3) (July 5, 2023)
  • K220565 — Hudson RCI Triflo II Incentive Deep Breathing Exerciser (October 25, 2022)
  • K203378 — Pulsehaler (March 31, 2021)
  • K192000 — D R Burton OxyPAP (February 19, 2020)
  • K181660 — Acapella Choice Blue Vibratory PEP Device (October 24, 2019)
  • K183108 — Combined Aerobika OPEP and VersaPAP device (August 16, 2019)
  • K182847 — Hudson RCI Voldyne Volumetric Exerciser (July 1, 2019)
  • K173918 — VersaPAP Positive Airway Pressure (PAP) Device (August 17, 2018)

FDA data resources