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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Carbon-Dioxide, Cutaneous
510(k) Number K883606
Device Name MODEL HP 15209A TRANS. COMBINED TCP02/TCPCO2 TRANS
Applicant
Hewlett-Packard Co.
175 Waltham St.
P.O.Box 9030
Waltham,  MA  02254
Applicant Contact DONALD J BARTH
Correspondent
Hewlett-Packard Co.
175 Waltham St.
P.O.Box 9030
Waltham,  MA  02254
Correspondent Contact DONALD J BARTH
Regulation Number868.2480
Classification Product Code
LKD  
Subsequent Product Code
KLK  
Date Received08/23/1988
Decision Date 12/16/1988
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
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