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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
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