Multi-Parameter Patient Monitor
K-Number: K211619 · 2022-12-29
Decision Date2022-12-29
Product CodeMHX
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Multi-Parameter Patient Monitor is a medical device manufactured by Shenzhen Comen Medical Instruments Co.,Ltd. It received FDA 510(k) clearance on 2022-12-29 under approval number K211619. 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 Multi-Parameter Patient Monitor?
Multi-Parameter Patient Monitor is a medical device that received FDA 510(k) clearance on 2022-12-29. It is manufactured by Shenzhen Comen Medical Instruments Co.,Ltd. The 510(k) number is K211619.
When was Multi-Parameter Patient Monitor approved by the FDA?
Multi-Parameter Patient Monitor received FDA 510(k) clearance on 2022-12-29, under approval number K211619.
What company makes Multi-Parameter Patient Monitor?
Multi-Parameter Patient Monitor is manufactured by Shenzhen Comen Medical Instruments Co.,Ltd.
What is the FDA product code for Multi-Parameter Patient Monitor?
The FDA product code for Multi-Parameter Patient Monitor is MHX.
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Other Devices by Shenzhen Comen Medical Instruments Co.,Ltd
K173454Multi-parameter Patient Monitor, models C30
K191106C50 and C80 Multi-parameter Patient Monitor
K250854Multi-parameter Patient Monitor (N10); Multi-parameter Patient Monitor (N12); Multi-parameter Patient Monitor (N15); Multi-parameter Patient Monitor (N10MPro); Multi-parameter Patient Monitor (N12MPro); Multi-parameter Patient Monitor (N15MPro)
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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.