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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 K913695
Device Name NELLCOR(R) N-180 PULSE OXIMETER
Applicant
NELLCOR, INC.
25495 WHITESELL ST.
HAYWARD,  CA  94545
Applicant Contact KENNETH R MICHAEL
Correspondent
NELLCOR, INC.
25495 WHITESELL ST.
HAYWARD,  CA  94545
Correspondent Contact KENNETH R MICHAEL
Regulation Number870.2700
Classification Product Code
DQA  
Date Received08/19/1991
Decision Date 11/13/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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