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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 K912412
Device Name VITALOGRAPH SPIROTRAC III
Applicant
Vitalograph , Ltd.
8347 Quivira Rd.
Lenexa,  KS  66215
Applicant Contact PETER MITCHELL
Correspondent
Vitalograph , Ltd.
8347 Quivira Rd.
Lenexa,  KS  66215
Correspondent Contact PETER MITCHELL
Regulation Number868.1840
Classification Product Code
BZG  
Date Received05/31/1991
Decision Date 10/15/1991
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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