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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plethysmograph, Volume
510(k) Number K223818
Device Name Model 9160 VitaloQUB
Applicant
Vitalograph Ireland, Ltd.
Gort Rd. Business Park
Ennis Co Clare,  IE V95 HFT4
Applicant Contact Tony O'Hanlon
Correspondent
ProMedic, LLC
131 Bay Pt. Dr. NE
St. Petersburg,  FL  33704
Correspondent Contact Paul Dryden
Regulation Number868.1760
Classification Product Code
JEH  
Subsequent Product Code
BTY  
Date Received12/21/2022
Decision Date 05/25/2023
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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