Sectra Digital Pathology Module (Version 3.3)— 510(k) K232208
Substantially EquivalentSectra AB
FDA 510(k) clearance K232208 for Sectra Digital Pathology Module (Version 3.3), Substantially Equivalent on 2024-04-16. Applicant: Sectra AB. Device class: 2.
Clearance details
- Applicant
- Sectra AB
- Product code
- Code PSY
- Device class
- Class 2
- Regulation
- 21 CFR 864.3700
- Advisory panel
- Pathology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Linköping, SE
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