FDA 510(k)

Passport Series Patient Monitors (Including Passport 8, Passport 12)

K-Number: K153448 · 2016-03-03

ApplicantShenzhen Mindray Bio-Medical Electronics Co., Ltd.

Decision Date2016-03-03

Product CodeMHX

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Passport Series Patient Monitors (Including Passport 8, Passport 12) 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 2016-03-03 under 510(k) 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. The listed applicant is Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. The 510(k) number is K153448.

When did Passport Series Patient Monitors (Including Passport 8, Passport 12) receive FDA 510(k) clearance?

Passport Series Patient Monitors (Including Passport 8, Passport 12) received FDA 510(k) clearance on 2016-03-03, under 510(k) number K153448.

Who is the listed applicant for Passport Series Patient Monitors (Including Passport 8, Passport 12)?

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 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.

Related Clinical Trials

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.

NCT06220565Evaluation of Product Effectiveness of the Intervention for Patients With Knee OsteoarthritisCOMPLETED

Other records listing Shenzhen Mindray Bio-Medical Electronics Co., Ltd. as applicant

View all 88 devices →

Related Devices (Code: MHX)

K251508Telemetry Monitor (iT30, iT50)Edan Instruments, Inc.K253277Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125PGe Medical Systems Information Technologies, Inc.K254209Radius VSM and AccessoriesMasimo Corporation K252840M12 Telemetry SystemGlobal Instrumentation, LLC K260098ePM Series Patient Monitor (ePM 10/ePM 10A/ePM 10C/Guardian plus/ ePM 12/ePM 12A/ePM 12C / ePM 15/ePM 15A/ePM 15C /ePM 10M/ ePM 10MA/ ePM 10MC/ePM 12M/ ePM 12MA/ ePM 12MC/ePM 15M/ ePM 15MA/ ePM 15MC)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.K250349Vista CMSShanghai Draeger Medical Instrument Co., Ltd.

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.