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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 K213210
Device Name Oxygen Concentrator, Model JAY-5AW
2F&3F, East Section, Building 12, Power Valley Pioneer Park,
No. 369 Huiyang St.
Baoding,  CN 071051
Applicant Contact Shi Lei
P&L Scientific, Inc.
1430 S. Dixie Hwy Suite 105
Coral Gables,  FL  33146
Correspondent Contact Jun Peng
Regulation Number868.5440
Classification Product Code
Date Received09/29/2021
Decision Date 12/08/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No