EXPLORER 3D— 510(k) K991815
Substantially EquivalentOur Scientific Intl., Inc.
FDA 510(k) clearance K991815 for EXPLORER 3D, Substantially Equivalent on 1999-08-13. Applicant: Our Scientific Intl., Inc.. Device class: 2.
Clearance details
- Applicant
- Our Scientific Intl., Inc.
- Product code
- Code MUJ
- Device class
- Class 2
- Regulation
- 21 CFR 892.5050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Pleasanton, CA, US
Recent devices under product code MUJ
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