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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
Applicant Contact DAVID A. C. GREEN
Correspondent
Nellcor Puritan Bennett, Inc.
2200 Faraday Ave.
Carlsbad,  CA  92008
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
Predetermined Change
Control Plan Authorized		 No
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