DINAMAP PRO SERIES MONITOR, MODELS 100, 200, 300, 400— 510(k) K992638
Substantially EquivalentCritikon Company, LLC
FDA 510(k) clearance K992638 for DINAMAP PRO SERIES MONITOR, MODELS 100, 200, 300, 400, Substantially Equivalent on 2000-02-24. Applicant: Critikon Company, LLC.
Clearance details
- Applicant
- Critikon Company, LLC
- Product code
- Code MWI
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tampa, FL, US
Adverse events under product code MWI
product code MWI- Death
- 16
- Malfunction
- 963
- Total
- 979
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.