MENTOR MDS
FDA 510(k) clearance K885155 · decided 1989-03-14
Clearance details
- K-number
- K885155
- Device name
- MENTOR MDS
- Applicant
- Imex
- Decision
- Substantially Equivalent
- Date received
- 1988-12-15
- Decision date
- 1989-03-14
- Days to decision
- 89 days
- Clearance type
- Traditional
- Product code
- IYN
- Device class
- 2
- Regulation number
- 892.1550
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Golden, CO, 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.