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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 a medical device manufactured by Edan Instruments, Inc.. It received FDA 510(k) clearance on 2022-08-11 under approval 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. It is manufactured by Edan Instruments, Inc.. The 510(k) number is K220308.

When was Patient Monitor: RespArray approved by the FDA?

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

What company makes Patient Monitor: RespArray?

Patient Monitor: RespArray is manufactured by Edan Instruments, Inc..

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

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

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Related Devices (Code: MHX)

K160981Patient MonitorEdan Instruments, Inc. K153707Nihon Kohden Vital Sign TelemeterNihon Kohden Corporation K160685Surveyor S4 Mobile MonitorMortara Instrument, Inc. K161531IntelliVue Patient Monitors MP2, MP5, MP5T, MP5SC, and Multi-Measurement Module X2; IntelliVue Patient Monitors MP20, MP30, MP40, MP50, MP60; IntelliVue Patient Monitors MP70, MP80, MP90;IntelliVue Patient Monitors MX400, MX430, MX450, MX500, MX550, MX600;IntelliVue Patient Monitors MX700, MX800Philips Medizin Systeme Boeblingen GmbH K153702M3290B Philips IntelliVue Information Center iXPhilips Medical Systems K160951Philips Efficia CMS200 Central Monitoring SystemPhilips Medical Systems

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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