FDA 510(k)

Accutorr 3 Vital Signs Monitor, Rosebud Vital Signs Monitor

K-Number: K221113 · 2022-12-02

ApplicantShenzhen Mindray Bio-Medical Electronics Co., Ltd.

Decision Date2022-12-02

Product CodeMWI

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Accutorr 3 Vital Signs Monitor, Rosebud Vital Signs Monitor 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 2022-12-02 under 510(k) number K221113. The device is classified under product code MWI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Accutorr 3 Vital Signs Monitor, Rosebud Vital Signs Monitor?

Accutorr 3 Vital Signs Monitor, Rosebud Vital Signs Monitor is a medical device that received FDA 510(k) clearance on 2022-12-02. The listed applicant is Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. The 510(k) number is K221113.

When did Accutorr 3 Vital Signs Monitor, Rosebud Vital Signs Monitor receive FDA 510(k) clearance?

Accutorr 3 Vital Signs Monitor, Rosebud Vital Signs Monitor received FDA 510(k) clearance on 2022-12-02, under 510(k) number K221113.

Who is the listed applicant for Accutorr 3 Vital Signs Monitor, Rosebud Vital Signs Monitor?

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 Accutorr 3 Vital Signs Monitor, Rosebud Vital Signs Monitor?

The FDA product code for Accutorr 3 Vital Signs Monitor, Rosebud Vital Signs Monitor is MWI.

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.

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

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Related Devices (Code: MWI)

K260438Vital Signs Monitor (CLEO2)Infinium Medical, Inc.K253417Masimo Root Monitoring SystemMasimo Corporation K253196Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400)Midmark Corporation K253436c-med0 alphaCosinuss GmbH K250135WAVE Clinical Platform (2.0.000)Baxter Healthcare Corp/ Excel Medical K241766QMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid)Fysicon BV

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.