Terumo Khuri Myocardial PH Monitoring System
FDA 510(k) K020967 · Terumo Cardiovascular Systems Corp.
510(k) numberK020967
Submission
- Device name
- Terumo Khuri Myocardial PH Monitoring System
- Applicant
- Terumo Cardiovascular Systems Corp.
Tistin, CA, US - Received
- March 25, 2002
- Decision date
- June 20, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CBZ – Analyzer, Ion, Hydrogen-Ion (Ph), Blood-Phase, Indwelling
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.1170
- Specialty
- Anesthesiology
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Questions and answers
When was Terumo Khuri Myocardial PH Monitoring System cleared by the FDA?
Terumo Khuri Myocardial PH Monitoring System (K020967) received a 510(k) decision of Substantially Equivalent on June 20, 2002, 87 days after the submission was received.
What is the product code of K020967?
The FDA product code is CBZ – Analyzer, Ion, Hydrogen-Ion (Ph), Blood-Phase, Indwelling, a Class II (moderate risk) device regulated under 21 CFR 868.1170.