RAREX & OPTEX X-RAY SCREENS
FDA 510(k) clearance K902039 · decided 1990-07-27
Clearance details
- K-number
- K902039
- Device name
- RAREX & OPTEX X-RAY SCREENS
- Applicant
- Mci Optonix, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1990-05-04
- Decision date
- 1990-07-27
- Days to decision
- 84 days
- Clearance type
- Traditional
- Product code
- EAM
- Device class
- 1
- Regulation number
- 892.1960
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Cedar Knolls, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.