NAVOYCDS— 510(k) K240558
Substantially EquivalentAlgodx AB
FDA 510(k) clearance K240558 for NAVOYCDS, Substantially Equivalent on 2024-07-22. Applicant: Algodx AB. Device class: 2.
Clearance details
- Applicant
- Algodx AB
- Product code
- Code PLB
- Device class
- Class 2
- Regulation
- 21 CFR 870.2300
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Stockholm, SE
Recent devices under product code PLB
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