TCM40 Monitoring System
FDA 510(k) K043003 · Radiometer Medical Aps
510(k) numberK043003
Submission
- Device name
- TCM40 Monitoring System
- Applicant
- Radiometer Medical Aps
Bronshoj, DK - Received
- November 1, 2004
- Decision date
- March 1, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LKD – Monitor, Carbon-Dioxide, Cutaneous
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.2480
- Specialty
- Anesthesiology
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Questions and answers
When was TCM40 Monitoring System cleared by the FDA?
TCM40 Monitoring System (K043003) received a 510(k) decision of Substantially Equivalent on March 1, 2005, 120 days after the submission was received.
What is the product code of K043003?
The FDA product code is LKD – Monitor, Carbon-Dioxide, Cutaneous, a Class II (moderate risk) device regulated under 21 CFR 868.2480.