RAREX & OPTEX X-RAY SCREENS— 510(k) K902039
Substantially EquivalentMci Optonix, Inc.
FDA 510(k) clearance K902039 for RAREX & OPTEX X-RAY SCREENS, Substantially Equivalent on 1990-07-27. Applicant: Mci Optonix, Inc.. Device class: 1.
Clearance details
- Applicant
- Mci Optonix, Inc.
- Product code
- Code EAM
- Device class
- Class 1
- Regulation
- 21 CFR 892.1960
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Cedar Knolls, NJ, US
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