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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 K893665
Device Name AEROSOL INHALATION MONITOR
Applicant
Vitalograph , Ltd.
8347 Quivira Rd.
Lenexa,  KS  66215
Applicant Contact LOVINA G FREEMAN
Correspondent
Vitalograph , Ltd.
8347 Quivira Rd.
Lenexa,  KS  66215
Correspondent Contact LOVINA G FREEMAN
Regulation Number868.5690
Classification Product Code
BWF  
Date Received05/15/1989
Decision Date 08/21/1989
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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