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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 K900333
Device Name E5280 COMBINED TRANSCUTANEOUS TCP02/TCPCO2 ELECT.
Applicant
Radiometer America, Inc.
811 Sharon Dr.
Westlake,  OH  44145
Applicant Contact DONALD BAKER
Correspondent
Radiometer America, Inc.
811 Sharon Dr.
Westlake,  OH  44145
Correspondent Contact DONALD BAKER
Regulation Number868.2480
Classification Product Code
LKD  
Date Received01/23/1990
Decision Date 04/16/1990
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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