Cleared Special

Maximus System

K200988 · Hill-Rom Services Pte, Ltd. · Anesthesiology
May 2020
Decision
41d
Days
Class 2
Risk

About This 510(k) Submission

K200988 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 May 26, 2020, 41 days after receiving the submission on April 15, 2020. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5905.

Submission Details

510(k) Number K200988 FDA.gov
FDA Decision Cleared SESE
Date Received April 15, 2020
Decision Date May 26, 2020
Days to Decision 41 days
Submission Type Special
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