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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 K001085
Device Name MODIFICATION TO ONYX, FINGER CLIP PULSE OXIMETER, MODEL 9500
Applicant
Nonin Medical, Inc.
2605 Fernbrook Ln., N.
Plymouth,  MN  55447
Applicant Contact RICHARD P BENNETT
Correspondent
Nonin Medical, Inc.
2605 Fernbrook Ln., N.
Plymouth,  MN  55447
Correspondent Contact RICHARD P BENNETT
Regulation Number870.2700
Classification Product Code
DQA  
Date Received04/04/2000
Decision Date 05/01/2000
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
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