Cleared Traditional

H500 Multi-Sensing Oximetry System

K192900 · Nonin Medical, Inc. · Anesthesiology
Jun 2020
Decision
258d
Days
Class 2
Risk

About This 510(k) Submission

K192900 is an FDA 510(k) clearance for the H500 Multi-Sensing Oximetry System, a Oximeter (Class II — Special Controls, product code DQA), submitted by Nonin Medical, Inc. (Plymouth, US). The FDA issued a Cleared decision on June 29, 2020, 258 days after receiving the submission on October 15, 2019. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 870.2700.

Submission Details

510(k) Number K192900 FDA.gov
FDA Decision Cleared SESE
Date Received October 15, 2019
Decision Date June 29, 2020
Days to Decision 258 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code DQA — Oximeter
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.2700

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