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FDA 510(k)

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 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 2017-08-23 under 510(k) 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. The listed applicant is Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. The 510(k) number is K170876.

When did Passport Series Patient Monitors(Passport 12m, Passport 17m) receive FDA 510(k) clearance?

Passport Series Patient Monitors(Passport 12m, Passport 17m) received FDA 510(k) clearance on 2017-08-23, under 510(k) number K170876.

Who is the listed applicant for Passport Series Patient Monitors(Passport 12m, Passport 17m)?

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(Passport 12m, Passport 17m)?

The FDA product code for Passport Series Patient Monitors(Passport 12m, Passport 17m) is MHX.

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

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.

View all 88 devices →

Related Devices (Code: MHX)

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.