AIMAGO EASYLDI MICROCIRCULATION CAMERA (STAND PLUS CAMERA ARM), AIMAGO EASY LDI STAND, INCLUDING 4-WHEELED STAND BASE AN
FDA 510(k) clearance K123216 · decided 2013-02-07
Clearance details
- K-number
- K123216
- Device name
- AIMAGO EASYLDI MICROCIRCULATION CAMERA (STAND PLUS CAMERA ARM), AIMAGO EASY LDI STAND, INCLUDING 4-WHEELED STAND BASE AN
- Applicant
- Aimago SA
- Decision
- Substantially Equivalent
- Date received
- 2012-10-15
- Decision date
- 2013-02-07
- Days to decision
- 115 days
- Clearance type
- Traditional
- Product code
- DPT
- Device class
- 2
- Regulation number
- 870.2120
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Lausanne, CH
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.