EOS
FDA 510(k) clearance K120721 · decided 2012-04-06
Clearance details
- K-number
- K120721
- Device name
- EOS
- Applicant
- Eos Imaging
- Decision
- Substantially Equivalent
- Date received
- 2012-03-08
- Decision date
- 2012-04-06
- Days to decision
- 29 days
- Clearance type
- Special
- Product code
- MQB
- Device class
- 2
- Regulation number
- 892.1680
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Washington, DC, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.