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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name generator, oxygen, portable
510(k) Number K203086
Device Name X-PLO2R
Belluscura LLC
5504 Democracy Dr, Suite 200
Plano,  TX  75024
Applicant Contact Sarah Clark
Regulatory Insight, Inc
33 Golden Eagle Ln
Littleton,  CO  80127
Correspondent Contact Kevin Walls
Regulation Number868.5440
Classification Product Code
Date Received10/13/2020
Decision Date 03/02/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No