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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Spirometer, Diagnostic
510(k) Number K212938
Device Name Vitalograph Model 6000 Alpha
Applicant
Vitalograph Ireland, Ltd.
Gort Rd. Business Park
Ennis Co Clare,  IE V95 HFT4
Applicant Contact Tony O'Hanlon
Correspondent
ProMedic Consulting, LLC
131 Bay Pt. Dr. NE
St. Petersburg,  FL  33704
Correspondent Contact Paul Dryden
Regulation Number868.1840
Classification Product Code
BZG  
Date Received09/15/2021
Decision Date 01/26/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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