Cleared Traditional

MINISCAV

K160950 · Sedation Systems, LLC · Anesthesiology
May 2017
Decision
395d
Days
Class 2
Risk

About This 510(k) Submission

K160950 is an FDA 510(k) clearance for the MINISCAV, a Apparatus, Gas-scavenging (Class II — Special Controls, product code CBN), submitted by Sedation Systems, LLC (Clearwater, US). The FDA issued a Cleared decision on May 5, 2017, 395 days after receiving the submission on April 5, 2016. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5430.

Submission Details

510(k) Number K160950 FDA.gov
FDA Decision Cleared SESE
Date Received April 05, 2016
Decision Date May 05, 2017
Days to Decision 395 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code CBN — Apparatus, Gas-scavenging
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5430