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FDA 510(k)

Infinity Acute Care System (IACS) Monitoring System

K-Number: K203088 · 2022-02-01

ApplicantDraeger Medical Systems, Inc.
Decision Date2022-02-01
Product CodeMHX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Infinity Acute Care System (IACS) Monitoring System is the device name listed in this FDA 510(k) record. The listed applicant is Draeger Medical Systems, Inc.. It received FDA 510(k) clearance on 2022-02-01 under 510(k) number K203088. The device is classified under product code MHX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Infinity Acute Care System (IACS) Monitoring System?

Infinity Acute Care System (IACS) Monitoring System is a medical device that received FDA 510(k) clearance on 2022-02-01. The listed applicant is Draeger Medical Systems, Inc.. The 510(k) number is K203088.

When did Infinity Acute Care System (IACS) Monitoring System receive FDA 510(k) clearance?

Infinity Acute Care System (IACS) Monitoring System received FDA 510(k) clearance on 2022-02-01, under 510(k) number K203088.

Who is the listed applicant for Infinity Acute Care System (IACS) Monitoring System?

The FDA 510(k) record lists Draeger Medical Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Infinity Acute Care System (IACS) Monitoring System?

The FDA product code for Infinity Acute Care System (IACS) Monitoring System is MHX.

Other records listing Draeger Medical Systems, Inc. as applicant

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Related Devices (Code: MHX)

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.

K251508Telemetry Monitor (iT30, iT50)Edan Instruments, Inc.K253277Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125PGe Medical Systems Information Technologies, Inc.K254209Radius VSM and AccessoriesMasimo CorporationK252840M12 Telemetry SystemGlobal Instrumentation, LLCK260098ePM Series Patient Monitor (ePM 10/ePM 10A/ePM 10C/Guardian plus/ ePM 12/ePM 12A/ePM 12C / ePM 15/ePM 15A/ePM 15C /ePM 10M/ ePM 10MA/ ePM 10MC/ePM 12M/ ePM 12MA/ ePM 12MC/ePM 15M/ ePM 15MA/ ePM 15MC)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.K250349Vista CMSShanghai Draeger Medical Instrument Co., Ltd.

Official Source

View on FDA Database →

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

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