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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 K895987
Device Name KELLER PULSE OXIMETER - KMS 850
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 Number870.2700
Classification Product Code
DQA  
Date Received10/12/1989
Decision Date 02/22/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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