Cleared Traditional

OptoMonitor 3

K202943 · Opsens, Inc. · Cardiovascular
Nov 2020
Decision
55d
Days
Class 2
Risk

About This 510(k) Submission

K202943 is an FDA 510(k) clearance for the OptoMonitor 3, a Transducer, Pressure, Catheter Tip (Class II — Special Controls, product code DXO), submitted by Opsens, Inc. (Quebec, CA). The FDA issued a Cleared decision on November 24, 2020, 55 days after receiving the submission on September 30, 2020. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2870.

Submission Details

510(k) Number K202943 FDA.gov
FDA Decision Cleared SESE
Date Received September 30, 2020
Decision Date November 24, 2020
Days to Decision 55 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DXO — Transducer, Pressure, Catheter Tip
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.2870