CARDIQ ANALYSIS III— 510(k) K041267
Substantially EquivalentGeneral Electric Medical Systems
FDA 510(k) clearance K041267 for CARDIQ ANALYSIS III, Substantially Equivalent on 2004-05-27. Applicant: General Electric Medical Systems. Device class: 2.
Clearance details
- Applicant
- General Electric Medical Systems
- Product code
- Code JAK
- Device class
- Class 2
- Regulation
- 21 CFR 892.1750
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Waukesha, WI, US
Recent devices under product code JAK
view allMore clearances from General Electric Medical Systems
view allAdverse events under product code JAK
product code JAK- Death
- 27
- Injury
- 571
- Malfunction
- 779
- Total
- 1,377
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.