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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name spirometer, therapeutic (incentive)
510(k) Number K222018
Device Name Breathe+
Applicant
PEEP Medical LLC dba GO2 Devices
9230 Katy Freeway, Suite 600
Houston,  TX  77055
Applicant Contact Paul Dryden
Correspondent
PEEP Medical LLC
131 Bay Point Drive
St. Petersburg,  FL  33704
Correspondent Contact Paul Dryden
Regulation Number868.5690
Classification Product Code
BWF  
Date Received07/08/2022
Decision Date 06/02/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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