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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 K891481
Device Name SIEMENS SIRECUST TRANSCUTANEOUS CARBON DIOXIDE
Applicant
Siemens Medical Electronics
16 Electronics Ave.
Danvers,  MA  01923
Applicant Contact ROBERT R MURFITT
Correspondent
Siemens Medical Electronics
16 Electronics Ave.
Danvers,  MA  01923
Correspondent Contact ROBERT R MURFITT
Regulation Number868.2480
Classification Product Code
LKD  
Subsequent Product Code
KLK  
Date Received03/17/1989
Decision Date 09/29/1989
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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