Cleared Traditional

K200401 - Apogee (FDA 510(k) Clearance)

K200401 · Incoba Ltd D/B/A Dynaris · Anesthesiology device
Nov 2020
Decision
270d
Days
Class 2
Risk

K200401 is an FDA 510(k) clearance for the Apogee. This device is classified as a Conserver, Oxygen (Class II - Special Controls, product code NFB).

Submitted by Incoba Ltd D/B/A Dynaris (Chesterfield, US). The FDA issued a Cleared decision on November 14, 2020, 270 days after receiving the submission on February 18, 2020.

This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5905.

Submission Details

510(k) Number K200401 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 18, 2020
Decision Date November 14, 2020
Days to Decision 270 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code NFB - Conserver, Oxygen
Device Class Class II - Special Controls
CFR Regulation 21 CFR 868.5905