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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 K991823
Device Name N-395 PULSE OXIMETER, MODEL N-395
Applicant
NELLCOR PURITAN BENNETT, INC.
2200 FARADAY AVE.
CARLSBAD,  CA  92008 -7208
Applicant Contact DAVID A. C. GREEN
Correspondent
NELLCOR PURITAN BENNETT, INC.
2200 FARADAY AVE.
CARLSBAD,  CA  92008 -7208
Correspondent Contact DAVID A. C. GREEN
Regulation Number870.2700
Classification Product Code
DQA  
Date Received05/28/1999
Decision Date 08/25/1999
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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