Cleared Traditional

OptoMonitor

K192340 · Opsens, Inc. · Cardiovascular
Dec 2019
Decision
106d
Days
Class 2
Risk

About This 510(k) Submission

K192340 is an FDA 510(k) clearance for the OptoMonitor, 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 December 12, 2019, 106 days after receiving the submission on August 28, 2019. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2870.

Submission Details

510(k) Number K192340 FDA.gov
FDA Decision Cleared SESE
Date Received August 28, 2019
Decision Date December 12, 2019
Days to Decision 106 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