CDI BLOOD PARAMETER MONITORING SYSTEM 500— 510(k) K133658
Substantially EquivalentTerumo Cardiovascular Systems Corp.
FDA 510(k) clearance K133658 for CDI BLOOD PARAMETER MONITORING SYSTEM 500, Substantially Equivalent on 2014-07-25. Applicant: Terumo Cardiovascular Systems Corp..
Clearance details
- Applicant
- Terumo Cardiovascular Systems Corp.
- Product code
- Code DRY
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Ann Arbor, MI, US
Adverse events under product code DRY
product code DRY- Death
- 5
- Total
- 5
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.