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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
510(k) Number K944400
Device Name PEDI-CAP
Applicant
NELLCOR, INC.
4280 HACIENDA DR.
P.O. BOX 8004
PLEASANTON,  CA  94588
Applicant Contact MARSHA J STONE
Correspondent
NELLCOR, INC.
4280 HACIENDA DR.
P.O. BOX 8004
PLEASANTON,  CA  94588
Correspondent Contact MARSHA J STONE
Regulation Number868.1400
Classification Product Code
CCK  
Date Received09/08/1994
Decision Date 09/27/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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