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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name humidifier, respiratory gas, (direct patient interface)
510(k) Number K193411
Device Name O2asis Personal Oxygen Humidifier
Perma Pure LLC
1001 New Hampshire Ave
Lakewood,  NJ  08701
Applicant Contact Sidra Hankins
Perma Pure LLC c/o ProMedic, LLC
131 Bay Point Dr. NE
St. Petersburg,  FL  33704
Correspondent Contact Paul Dryden
Regulation Number868.5450
Classification Product Code
Date Received12/09/2019
Decision Date 11/12/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No