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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 K952222
Device Name NELLCOR N-20PA PORTABLE PULSE OXIMETER
Applicant
Nellcor, Inc.
4280 Hacienda Dr.
P.O. Box 8004
Pleasanton,  CA  94588
Applicant Contact DONNA PAGE
Correspondent
Nellcor, Inc.
4280 Hacienda Dr.
P.O. Box 8004
Pleasanton,  CA  94588
Correspondent Contact DONNA PAGE
Regulation Number870.2700
Classification Product Code
DQA  
Date Received05/12/1995
Decision Date 08/15/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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