Passport Series Patient Monitors(Passport 12m, Passport 17m)
K-Number: K170876 · 2017-08-23
Decision Date2017-08-23
Product CodeMHX
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Passport Series Patient Monitors(Passport 12m, Passport 17m) is a medical device manufactured by Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. It received FDA 510(k) clearance on 2017-08-23 under approval number K170876. 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(Passport 12m, Passport 17m)?
Passport Series Patient Monitors(Passport 12m, Passport 17m) is a medical device that received FDA 510(k) clearance on 2017-08-23. It is manufactured by Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. The 510(k) number is K170876.
When was Passport Series Patient Monitors(Passport 12m, Passport 17m) approved by the FDA?
Passport Series Patient Monitors(Passport 12m, Passport 17m) received FDA 510(k) clearance on 2017-08-23, under approval number K170876.
What company makes Passport Series Patient Monitors(Passport 12m, Passport 17m)?
Passport Series Patient Monitors(Passport 12m, Passport 17m) is manufactured by Shenzhen Mindray Bio-Medical Electronics Co., Ltd..
What is the FDA product code for Passport Series Patient Monitors(Passport 12m, Passport 17m)?
The FDA product code for Passport Series Patient Monitors(Passport 12m, Passport 17m) 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.