SeeFactorCT3— 510(k) K190856
Substantially EquivalentEpica International, Inc.
FDA 510(k) clearance K190856 for SeeFactorCT3, Substantially Equivalent on 2019-09-20. Applicant: Epica International, Inc.. Device class: 2.
Clearance details
- Applicant
- Epica International, Inc.
- Product code
- Code OAS
- Device class
- Class 2
- Regulation
- 21 CFR 892.1750
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Clemente, CA, US
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