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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 K993637
Device Name N-395 PULSE OXIMETER, WITH EXTENDED DEVICE CLAIMS
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 Received10/28/1999
Decision Date 11/24/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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