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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name oximeter
510(k) Number K982331
Device Name KELLER PULSE OXIMETER, MODEL 850+
Applicant
KELLER MEDICAL SPECIALTIES PRODUCTS, INC.
42609 CRAWFORD RD.
ANTIOCH,  IL  60002
Applicant Contact JEAN KELLER
Correspondent
KELLER MEDICAL SPECIALTIES PRODUCTS, INC.
42609 CRAWFORD RD.
ANTIOCH,  IL  60002
Correspondent Contact JEAN KELLER
Regulation Number870.2700
Classification Product Code
DQA  
Date Received07/02/1998
Decision Date 09/11/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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