ELOQUENCE, INTEGRATED FUNCTIONAL IMAGING SYSTEM
FDA 510(k) clearance K023130 · decided 2002-10-11
Clearance details
- K-number
- K023130
- Device name
- ELOQUENCE, INTEGRATED FUNCTIONAL IMAGING SYSTEM
- Applicant
- Mri Devices Corp.
- Decision
- Substantially Equivalent
- Date received
- 2002-09-20
- Decision date
- 2002-10-11
- Days to decision
- 21 days
- Clearance type
- Special
- Product code
- LNH
- Device class
- 2
- Regulation number
- 892.1000
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Waukesha, WI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.