Cleared Traditional

K220591 - Proxima (FDA 510(k) Clearance)

K220591 · Dynasthetics, LLC · Anesthesiology device
Dec 2022
Decision
289d
Days
Class 2
Risk

K220591 is an FDA 510(k) clearance for the Proxima. This device is classified as a Conserver, Oxygen (Class II - Special Controls, product code NFB).

Submitted by Dynasthetics, LLC (Salt Lake City, US). The FDA issued a Cleared decision on December 15, 2022, 289 days after receiving the submission on March 1, 2022.

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

Submission Details

510(k) Number K220591 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 2022
Decision Date December 15, 2022
Days to Decision 289 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