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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 K972468
Device Name NPB-195 PULSE OXIMETER
Applicant
Nellcor Puritan Bennett, Inc.
11150 Thompson Ave.
Lenexa,  KS  66219
Applicant Contact ROGER D BROWN
Correspondent
Nellcor Puritan Bennett, Inc.
11150 Thompson Ave.
Lenexa,  KS  66219
Correspondent Contact ROGER D BROWN
Regulation Number870.2700
Classification Product Code
DQA  
Date Received07/01/1997
Decision Date 09/25/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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