ALLON 2001 VERSION 5— 510(k) K024128
Substantially EquivalentMtre Advanced Technology , Ltd.
FDA 510(k) clearance K024128 for ALLON 2001 VERSION 5, Substantially Equivalent on 2003-02-10. Applicant: Mtre Advanced Technology , Ltd.. Device class: 2.
Clearance details
- Applicant
- Mtre Advanced Technology , Ltd.
- Product code
- Code DWJ
- Device class
- Class 2
- Regulation
- 21 CFR 870.5900
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Centerville, OH, US
Recent devices under product code DWJ
view allMore clearances from Mtre Advanced Technology , Ltd.
view allAdverse events under product code DWJ
product code DWJ- Death
- 7
- Injury
- 679
- Malfunction
- 17,477
- Total
- 18,163
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 K024128
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 K024128.
Data sourced from openFDA. This site is unofficial and independent of the FDA.