Decision Date2020-05-07
Product CodeMHX
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Patient Monitor is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. It received FDA 510(k) clearance on 2020-05-07 under 510(k) number K192972. 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?
Patient Monitor is a medical device that received FDA 510(k) clearance on 2020-05-07. The listed applicant is Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. The 510(k) number is K192972.
When did Patient Monitor receive FDA 510(k) clearance?
Patient Monitor received FDA 510(k) clearance on 2020-05-07, under 510(k) number K192972.
Who is the listed applicant for Patient Monitor?
The FDA 510(k) record lists Shenzhen Mindray Bio-Medical Electronics Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Patient Monitor?
The FDA product code for Patient Monitor is MHX.
Other records listing Shenzhen Mindray Bio-Medical Electronics Co., Ltd. as applicant
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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.
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.