PATIENT MONITOR, MODELS DASH 3000, 4000 AND 5000— 510(k) K051367
Substantially EquivalentGe Medical Systems Information Technologies
FDA 510(k) clearance K051367 for PATIENT MONITOR, MODELS DASH 3000, 4000 AND 5000, Substantially Equivalent on 2005-06-20. Applicant: Ge Medical Systems Information Technologies. Device class: 2.
Clearance details
- Applicant
- Ge Medical Systems Information Technologies
- Product code
- Code MHX
- Device class
- Class 2
- Regulation
- 21 CFR 870.1025
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Tampa, FL, US
Recent devices under product code MHX
view allMore clearances from Ge Medical Systems Information Technologies
view allAdverse events under product code MHX
product code MHX- Death
- 580
- Injury
- 2,441
- Malfunction
- 12,655
- Other
- 3
- Total
- 15,679
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 →
Recalls naming K051367
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K051367.
Data sourced from openFDA. This site is unofficial and independent of the FDA.