CARD EP
FDA 510(k) clearance K031261 · decided 2003-05-06
Clearance details
- K-number
- K031261
- Device name
- CARD EP
- Applicant
- GE Medical Systems
- Decision
- Substantially Equivalent
- Date received
- 2003-04-21
- Decision date
- 2003-05-06
- Days to decision
- 15 days
- Clearance type
- Traditional
- Product code
- JAK
- Device class
- 2
- Regulation number
- 892.1750
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Milwaukee, WI, US
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.