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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name calculator, predicted values, pulmonary function
510(k) Number K930085
Device Name VITALOGRAPH DATA STORAGE SPIROMETER
Applicant
VITALOGRAPH LTD.
8347 QUIVIRA RD.
LENEXA,  KS  66215
Applicant Contact PHIL HEMES
Correspondent
VITALOGRAPH LTD.
8347 QUIVIRA RD.
LENEXA,  KS  66215
Correspondent Contact PHIL HEMES
Regulation Number868.1890
Classification Product Code
BTY  
Date Received01/07/1993
Decision Date 07/26/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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