OPTIRAD— 510(k) K993895
Substantially EquivalentPermedics, Inc.
FDA 510(k) clearance K993895 for OPTIRAD, Substantially Equivalent on 2000-06-02. Applicant: Permedics, Inc.. Device class: 2.
Clearance details
- Applicant
- Permedics, 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
- Irvine, CA, US
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