FDA 510(k)

Maximus System

K-Number: K192143 · 2020-02-14

Decision Date2020-02-14

Product CodeNHJ

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

Maximus System is the device name listed in this FDA 510(k) record. The listed applicant is Hill-Rom Services Pte, Ltd.. It received FDA 510(k) clearance on 2020-02-14 under 510(k) number K192143. The device is classified under product code NHJ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Maximus System?

Maximus System is a medical device that received FDA 510(k) clearance on 2020-02-14. The listed applicant is Hill-Rom Services Pte, Ltd.. The 510(k) number is K192143.

When did Maximus System receive FDA 510(k) clearance?

Maximus System received FDA 510(k) clearance on 2020-02-14, under 510(k) number K192143.

Who is the listed applicant for Maximus System?

The FDA 510(k) record lists Hill-Rom Services Pte, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Maximus System?

The FDA product code for Maximus System is NHJ.

Other records listing Hill-Rom Services Pte, Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K200988Maximus System K163378Monarch Airway Clearance System K151689MetaNeb 4 System

Related Devices (Code: NHJ)

K253001KT Airway Clearance Device II (KT-3); KT Airway Clearance Device II (KT-5)Hunan Ruijiong Biotech Co., Ltd.K242438ClearoBreas Medical AB K231728BiWaze Clear SystemAbmrc, LLC K213564BiWaze Clear SystemAbmrc, LLC K200988Maximus SystemHill-Rom Services Pte, Ltd.K191912BiWaze CoughAbmrc, LLC

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.