Cleared Traditional

Maximus System

K192143 · Hill-Rom Services Pte, Ltd. · Anesthesiology
Feb 2020
Decision
190d
Days
Class 2
Risk

About This 510(k) Submission

K192143 is an FDA 510(k) clearance for the Maximus System, a Device, Positive Pressure Breathing, Intermittent (Class II — Special Controls, product code NHJ), submitted by Hill-Rom Services Pte, Ltd. (Singapore, SG). The FDA issued a Cleared decision on February 14, 2020, 190 days after receiving the submission on August 8, 2019. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5905.

Submission Details

510(k) Number K192143 FDA.gov
FDA Decision Cleared SESE
Date Received August 08, 2019
Decision Date February 14, 2020
Days to Decision 190 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code NHJ — Device, Positive Pressure Breathing, Intermittent
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5905