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510(k) K900333

E5280 COMBINED TRANSCUTANEOUS TCP02/TCPCO2 ELECT. by Radiometer America, Inc. — Product Code LKD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 16, 1990
Date Received
January 23, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Carbon-Dioxide, Cutaneous
Device Class
Class II
Regulation Number
868.2480
Review Panel
AN
Submission Type

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