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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 K002690
Device Name MODEL 2500, PALMSAT HAND HELD PULSE OXIMETER, MODEL 2500
Applicant
Nonin Medical, Inc.
2605 Fernbrook Lane, N.
Plymouth,  MN  55447 -4755
Applicant Contact RICHARD P BENNETT
Correspondent
Nonin Medical, Inc.
2605 Fernbrook Lane, N.
Plymouth,  MN  55447 -4755
Correspondent Contact RICHARD P BENNETT
Regulation Number870.2700
Classification Product Code
DQA  
Date Received08/29/2000
Decision Date 10/11/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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