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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
510(k) Number K914576
Device Name KELLER CARDIAC MONITOR MEDIL KMS870
Applicant
KELLER MEDICAL SPECIALTIES PRODUCTS, INC.
42609 CRAWFORD RD.
ANTIOCH,  IL  60002
Applicant Contact JAY KELLER
Correspondent
KELLER MEDICAL SPECIALTIES PRODUCTS, INC.
42609 CRAWFORD RD.
ANTIOCH,  IL  60002
Correspondent Contact JAY KELLER
Regulation Number870.2300
Classification Product Code
DRT  
Date Received10/15/1991
Decision Date 12/30/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
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