Visby Medical Respiratory Health Test— 510(k) K242526
Substantially EquivalentVisby Medical, Inc.
FDA 510(k) clearance K242526 for Visby Medical Respiratory Health Test, Substantially Equivalent on 2025-02-19. Applicant: Visby Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Visby Medical, Inc.
- Product code
- Code QOF
- Device class
- Class 2
- Regulation
- 21 CFR 866.3981
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Dual Track
- Location
- San Jose, CA, US
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