Premarket Approval (PMA)

Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.

• Device: RADIOMETER TCM-10 TRANSCUTANEOUS CARBON DIOXIDE MO
• Generic Name: MONITOR, CARBON-DIOXIDE, CUTANEOUS
• Regulation Number: 868.2480
• Applicant: Radiometer America, Inc.; 811 Sharon Dr.; Westlake, OH 44145
• PMA Number: P800043
• Supplement Number: S003
• Date Received: 09/04/1984
• Decision Date: 02/22/1985
• Product Code: LKD
• Advisory Committee: Anesthesiology
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No