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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 K854526
Device Name VITALOGRAPH COMPACT
Applicant
VITALOGRAPH LTD.
8347 QUIVIRA RD.
LENEXA,  KS  66215
Applicant Contact LOVINA G FREEMAN
Correspondent
VITALOGRAPH LTD.
8347 QUIVIRA RD.
LENEXA,  KS  66215
Correspondent Contact LOVINA G FREEMAN
Regulation Number868.1840
Classification Product Code
BZG  
Date Received11/13/1985
Decision Date 12/24/1985
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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