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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
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