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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 K160636
Device Name iPEP System and vPEP
Applicant
D R BURTON HEALTHCARE LLC
3936 S FIELDS ST
FARMVILLE,  NC  27828
Applicant Contact DENNIS COOK
Correspondent
D R BURTON HEALTHCARE LLC
3936 S FIELDS ST
FARMVILLE,  NC  27828
Correspondent Contact PAUL DRYDEN
Regulation Number868.5690
Classification Product Code
BWF  
Date Received03/07/2016
Decision Date 08/03/2016
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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