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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 K862161
Device Name OSC-80 OXIMETER
Applicant
Waters Instruments, Inc.
2411 Seventh St. NW
P.O. Box 6117
Rochester,  MN  55903 -6117
Applicant Contact LEWIS N HARROLD
Correspondent
Waters Instruments, Inc.
2411 Seventh St. NW
P.O. Box 6117
Rochester,  MN  55903 -6117
Correspondent Contact LEWIS N HARROLD
Regulation Number870.2700
Classification Product Code
DQA  
Date Received06/06/1986
Decision Date 08/18/1986
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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