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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 West
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
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