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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name System, Measurement, Blood-Pressure, Non-Invasive
510(k) Number K990648
Device Name KELLER VITAL SIGNS MONITOR, KMS 890+
Applicant
KELLER MEDICAL SPECIALTIES PRODUCTS, INC.
42609 CRAWFORD RD.
ANTIOCH,  IL  60002
Applicant Contact JEAN WAGNER
Correspondent
KELLER MEDICAL SPECIALTIES PRODUCTS, INC.
42609 CRAWFORD RD.
ANTIOCH,  IL  60002
Correspondent Contact JEAN WAGNER
Regulation Number870.1130
Classification Product Code
DXN  
Subsequent Product Code
DQA  
Date Received03/01/1999
Decision Date 08/10/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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