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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
Predetermined Change
Control Plan Authorized		 No
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