Apogee— 510(k) K200401
Substantially EquivalentIncoba Ltd D/B/A Dynaris
FDA 510(k) clearance K200401 for Apogee, Substantially Equivalent on 2020-11-14. Applicant: Incoba Ltd D/B/A Dynaris. Device class: 2.
Clearance details
- Applicant
- Incoba Ltd D/B/A Dynaris
- Product code
- Code NFB
- Device class
- Class 2
- Regulation
- 21 CFR 868.5905
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Chesterfield, MO, US
Recent devices under product code NFB
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