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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 K905225
Device Name HBO CABLE ASSEMBLY, RADIOMETER TC-02
Applicant
SECHRIST
2820 GRETTA LN.
ANAHEIM,  CA  92306
Applicant Contact SANDRA DAVIS
Correspondent
SECHRIST
2820 GRETTA LN.
ANAHEIM,  CA  92306
Correspondent Contact SANDRA DAVIS
Regulation Number868.2480
Classification Product Code
LKD  
Date Received11/20/1990
Decision Date 04/10/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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