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FDA 510(k)

Patient Monitor: RespArray

K-Number: K220308 · 2022-08-11

ApplicantEdan Instruments, Inc.
Decision Date2022-08-11
Product CodeMHX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Patient Monitor: RespArray is the device name listed in this FDA 510(k) record. The listed applicant is Edan Instruments, Inc.. It received FDA 510(k) clearance on 2022-08-11 under 510(k) number K220308. 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 Patient Monitor: RespArray?

Patient Monitor: RespArray is a medical device that received FDA 510(k) clearance on 2022-08-11. The listed applicant is Edan Instruments, Inc.. The 510(k) number is K220308.

When did Patient Monitor: RespArray receive FDA 510(k) clearance?

Patient Monitor: RespArray received FDA 510(k) clearance on 2022-08-11, under 510(k) number K220308.

Who is the listed applicant for Patient Monitor: RespArray?

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

What is the FDA product code for Patient Monitor: RespArray?

The FDA product code for Patient Monitor: RespArray is MHX.

Other records listing Edan Instruments, 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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