Cleared Traditional

Nox RIP Belts & Cables

K151361 · Nox Medical Ehf · Anesthesiology
Nov 2015
Decision
169d
Days
Class 2
Risk

About This 510(k) Submission

K151361 is an FDA 510(k) clearance for the Nox RIP Belts & Cables, a Ventilatory Effort Recorder (Class II — Special Controls, product code MNR), submitted by Nox Medical Ehf (Reykjavik, IS). The FDA issued a Cleared decision on November 6, 2015, 169 days after receiving the submission on May 21, 2015. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.2375.

Submission Details

510(k) Number K151361 FDA.gov
FDA Decision Cleared SESE
Date Received May 21, 2015
Decision Date November 06, 2015
Days to Decision 169 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code MNR — Ventilatory Effort Recorder
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.2375