Passport Series Patient Monitors (Including Passport 8, Passport 12)
K-Number: K153448 · 2016-03-03
Decision Date2016-03-03
Product CodeMHX
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Passport Series Patient Monitors (Including Passport 8, Passport 12) is a medical device manufactured by Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. It received FDA 510(k) clearance on 2016-03-03 under approval number K153448. 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 8, Passport 12)?
Passport Series Patient Monitors (Including Passport 8, Passport 12) is a medical device that received FDA 510(k) clearance on 2016-03-03. It is manufactured by Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. The 510(k) number is K153448.
When was Passport Series Patient Monitors (Including Passport 8, Passport 12) approved by the FDA?
Passport Series Patient Monitors (Including Passport 8, Passport 12) received FDA 510(k) clearance on 2016-03-03, under approval number K153448.
What company makes Passport Series Patient Monitors (Including Passport 8, Passport 12)?
Passport Series Patient Monitors (Including Passport 8, Passport 12) is manufactured by Shenzhen Mindray Bio-Medical Electronics Co., Ltd..
What is the FDA product code for Passport Series Patient Monitors (Including Passport 8, Passport 12)?
The FDA product code for Passport Series Patient Monitors (Including Passport 8, Passport 12) 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.