Cleared Traditional

OptoMonitor II

K161263 · Opsens, Inc. · Cardiovascular
Sep 2016
Decision
131d
Days
Class 2
Risk

About This 510(k) Submission

K161263 is an FDA 510(k) clearance for the OptoMonitor II, 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 September 13, 2016, 131 days after receiving the submission on May 5, 2016. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2870.

Submission Details

510(k) Number K161263 FDA.gov
FDA Decision Cleared SESE
Date Received May 05, 2016
Decision Date September 13, 2016
Days to Decision 131 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