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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 K971946
Device Name NPB-190 PULSE OXIMETER (NPB-190)
Applicant
NELLCOR PURITAN BENNETT, INC.
11150 THOMPSON AVE.
LENEXA,  KS  66219 -2301
Applicant Contact ROGER D BROWN
Correspondent
NELLCOR PURITAN BENNETT, INC.
11150 THOMPSON AVE.
LENEXA,  KS  66219 -2301
Correspondent Contact ROGER D BROWN
Regulation Number870.2700
Classification Product Code
DQA  
Date Received05/27/1997
Decision Date 08/25/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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