Corometrics Transcutaneous TCPO2/CO2 Module
FDA 510(k) K980756 · Ge Medical Systems Information Technologies
510(k) numberK980756
Submission
- Device name
- Corometrics Transcutaneous TCPO2/CO2 Module
- Applicant
- Ge Medical Systems Information Technologies
Wallingford, CT, US - Received
- February 27, 1998
- Decision date
- November 5, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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 Corometrics Transcutaneous TCPO2/CO2 Module cleared by the FDA?
Corometrics Transcutaneous TCPO2/CO2 Module (K980756) received a 510(k) decision of Substantially Equivalent on November 5, 1998, 251 days after the submission was received.
What is the product code of K980756?
The FDA product code is LKD – Monitor, Carbon-Dioxide, Cutaneous, a Class II (moderate risk) device regulated under 21 CFR 868.2480.