Cleared Traditional

OptoMonitor 3

K193620 · Opsens, Inc. · Cardiovascular
Jun 2020
Decision
175d
Days
Class 2
Risk

About This 510(k) Submission

K193620 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 June 18, 2020, 175 days after receiving the submission on December 26, 2019. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2870.

Submission Details

510(k) Number K193620 FDA.gov
FDA Decision Cleared SESE
Date Received December 26, 2019
Decision Date June 18, 2020
Days to Decision 175 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