DINAMAP PROCARE SERIES MONITOR, MODELS 100N, 200N, 300N, 400N— 510(k) K022193
Substantially EquivalentGe Medical Systems Information Technologies
FDA 510(k) clearance K022193 for DINAMAP PROCARE SERIES MONITOR, MODELS 100N, 200N, 300N, 400N, Substantially Equivalent on 2002-08-01. Applicant: Ge Medical Systems Information Technologies.
Clearance details
- Applicant
- Ge Medical Systems Information Technologies
- Product code
- Code DQA
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Tampa, FL, US
Adverse events under product code DQA
product code DQA- Death
- 66
- Malfunction
- 2,867
- Other
- 1
- Total
- 2,934
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.