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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilator, Continuous, Facility Use
510(k) Number K232365
Device Name Vivo 45 LS
Applicant
Oconnell Regulatory Consultants, Inc.
44 Oak St.
Stoneham,  MA  02180
Applicant Contact Maureen OConnell
Correspondent
Oconnell Regulatory Consultants, Inc.
44 Oak St.
Stoneham,  MA  02180
Correspondent Contact Maureen OConnell
Regulation Number868.5895
Classification Product Code
CBK  
Subsequent Product Codes
BTT   CCK   DQA   NOU  
Date Received08/07/2023
Decision Date 12/19/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
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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