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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
Recalls CDRH Recalls
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