Apogee— 510(k) K200401

Substantially Equivalent

Incoba 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.

Clearance details

Applicant
Incoba Ltd D/B/A Dynaris
Product code
Code NFB
Advisory panel
Anesthesiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Chesterfield, MO, US
Download summary PDFView on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.