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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 K000314
Device Name INCENTIVE SPIROMETER
Applicant
ENGINEERED MEDICAL SYSTEMS
2055 EXECUTIVE DR.
INDIANAPOLIS,  IN  46241
Applicant Contact BONNIE HOLLY
Correspondent
ENGINEERED MEDICAL SYSTEMS
2055 EXECUTIVE DR.
INDIANAPOLIS,  IN  46241
Correspondent Contact BONNIE HOLLY
Regulation Number868.5690
Classification Product Code
BWF  
Date Received02/01/2000
Decision Date 04/12/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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