FDA 510(k)

Accutorr 7/VS-900/VS-900c Vital Signs Monitor

K-Number: K182821 · 2019-03-27

ApplicantShenzhen Mindray Bio-Medical Electronics Co., Ltd.

Decision Date2019-03-27

Product CodeMWI

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Accutorr 7/VS-900/VS-900c 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 2019-03-27 under 510(k) number K182821. 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 7/VS-900/VS-900c Vital Signs Monitor?

Accutorr 7/VS-900/VS-900c Vital Signs Monitor is a medical device that received FDA 510(k) clearance on 2019-03-27. The listed applicant is Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. The 510(k) number is K182821.

When did Accutorr 7/VS-900/VS-900c Vital Signs Monitor receive FDA 510(k) clearance?

Accutorr 7/VS-900/VS-900c Vital Signs Monitor received FDA 510(k) clearance on 2019-03-27, under 510(k) number K182821.

Who is the listed applicant for Accutorr 7/VS-900/VS-900c 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 7/VS-900/VS-900c Vital Signs Monitor?

The FDA product code for Accutorr 7/VS-900/VS-900c Vital Signs Monitor is MWI.

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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.