CONCEPT ONE— 510(k) K933777
Substantially EquivalentInnerscan, Inc.
FDA 510(k) clearance K933777 for CONCEPT ONE, Substantially Equivalent on 1993-12-13. Applicant: Innerscan, Inc.. Device class: 1.
Clearance details
- Applicant
- Innerscan, Inc.
- 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
- Wheeling, IL, US
Recent devices under product code IZO
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