CORRIDOR4DM
FDA 510(k) clearance K080575 · decided 2008-05-13
Clearance details
- K-number
- K080575
- Device name
- CORRIDOR4DM
- Applicant
- Invia
- Decision
- Substantially Equivalent
- Date received
- 2008-02-29
- Decision date
- 2008-05-13
- Days to decision
- 74 days
- Clearance type
- Traditional
- Product code
- KPS
- Device class
- 2
- Regulation number
- 892.1200
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Ashland, MA, 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.