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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Spirometer, Therapeutic (Incentive)
510(k) Number K172388
Device Name VPOD ITPR
Applicant
Advanced Circulatory System, A Wholly Owned Subsidiary OF
Zoll
1905 County Rd. C W.
Roseville,  MN  55113
Applicant Contact Anja Metzger
Correspondent
Advanced Circulatory System, A Wholly Owned Subsidiary OF
Zoll C/O Promedic, Llc
131 Bay Point Dr. NE
St. Petersburg,  FL  33704
Correspondent Contact Paul E. Dryden
Regulation Number868.5690
Classification Product Code
BWF  
Date Received08/08/2017
Decision Date 12/22/2017
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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