ChestView US— 510(k) K241620
Substantially EquivalentGleamer Sas
FDA 510(k) clearance K241620 for ChestView US, Substantially Equivalent on 2025-02-27. Applicant: Gleamer Sas. Device class: 2.
Clearance details
- Applicant
- Gleamer Sas
- Product code
- Code MYN
- Device class
- Class 2
- Regulation
- 21 CFR 892.2070
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Paris, FR
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