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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Oximeter
510(k) Number K231288
Device Name Vyvo
Applicant
Vyvo Technology Corp.(Vt)
123 NW 23 Rd. St.
Miami,  FL  33127 -4409
Applicant Contact Alfonso Cioffi
Correspondent
Shenzhen Global Medical Technology Services Co., Ltd.
Rm. 1702 17th Floor, Shenzhen Taifeng Bldg., B0. 86,
Qianjin 1st Rd., Bao An
Shenzhen,  CN 8100
Correspondent Contact Aileen Fu
Regulation Number870.2700
Classification Product Code
DQA  
Subsequent Product Code
DPS  
Date Received05/04/2023
Decision Date 03/04/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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