Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)
K-Number: K190011 · 2019-07-10
Decision Date2019-07-10
Product CodeMHX
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1) is a medical device manufactured by Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. It received FDA 510(k) clearance on 2019-07-10 under approval number K190011. 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 Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)?
Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1) is a medical device that received FDA 510(k) clearance on 2019-07-10. It is manufactured by Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. The 510(k) number is K190011.
When was Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1) approved by the FDA?
Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1) received FDA 510(k) clearance on 2019-07-10, under approval number K190011.
What company makes Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)?
Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1) is manufactured by Shenzhen Mindray Bio-Medical Electronics Co., Ltd..
What is the FDA product code for Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)?
The FDA product code for Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1) is MHX.
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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.