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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nebulizer (Direct Patient Interface)
510(k) Number K072670
Device Name MODIFICATION TO: EFLOW ELECTRONIC INHALER/NEBULIZER
Applicant
PARI INNOVATIVE MANUFACTURERS, INC.
2943 OAKLAKE BLVD.
MIDLOTHIAN,  VA  23112
Applicant Contact JAMES MCINTIRE
Correspondent
INTERTEK TESTING SERVICES
2307 EAST AURORA ROAD
UNIT B7
TWINSBURG,  OH  44087
Correspondent Contact JAY KOGOMA
Regulation Number868.5630
Classification Product Code
CAF  
Date Received09/21/2007
Decision Date 12/13/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party Yes
Combination Product Yes
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