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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Oximeter, Ear
510(k) Number K944760
Device Name DURA-Y OXYGEN TRANSDUCER, EAR CLIP
Applicant
Nellcor, Inc.
2391 Fenton St.
Chula Vista,  CA  91914
Applicant Contact GERALD PALECKI
Correspondent
Nellcor, Inc.
2391 Fenton St.
Chula Vista,  CA  91914
Correspondent Contact GERALD PALECKI
Regulation Number870.2710
Classification Product Code
DPZ  
Date Received09/27/1994
Decision Date 10/17/1994
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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