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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Spirometer, Diagnostic
510(k) Number K000599
Device Name VITALOGRAPH BASE STATION
Applicant
Vitalograph, Inc.
8347 Quivira Rd.
Lenexa,  KS  66215
Applicant Contact PHIL HEMES
Correspondent
Vitalograph, Inc.
8347 Quivira Rd.
Lenexa,  KS  66215
Correspondent Contact PHIL HEMES
Regulation Number868.1840
Classification Product Code
BZG  
Date Received02/22/2000
Decision Date 09/08/2000
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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