OPTIMA— 510(k) K913222
Substantially EquivalentOlympic Controls Corp.
FDA 510(k) clearance K913222 for OPTIMA, Substantially Equivalent on 1991-12-20. Applicant: Olympic Controls Corp.. Device class: 1.
Clearance details
- Applicant
- Olympic Controls Corp.
- Product code
- Code IZO
- Device class
- Class 1
- Regulation
- 21 CFR 892.1700
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Elgin, IL, US
Recent devices under product code IZO
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