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FDA 510(k)

Accutorr 7/VS-900 Vital Signs Monitor

K-Number: K170712 · 2017-08-02

ApplicantShenzhen Mindray Bio-Meidcal Electronics Co., Ltd.
Decision Date2017-08-02
Product CodeMWI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Accutorr 7/VS-900 Vital Signs Monitor is a medical device manufactured by Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.. It received FDA 510(k) clearance on 2017-08-02 under approval number K170712. 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 Vital Signs Monitor?

Accutorr 7/VS-900 Vital Signs Monitor is a medical device that received FDA 510(k) clearance on 2017-08-02. It is manufactured by Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.. The 510(k) number is K170712.

When was Accutorr 7/VS-900 Vital Signs Monitor approved by the FDA?

Accutorr 7/VS-900 Vital Signs Monitor received FDA 510(k) clearance on 2017-08-02, under approval number K170712.

What company makes Accutorr 7/VS-900 Vital Signs Monitor?

Accutorr 7/VS-900 Vital Signs Monitor is manufactured by Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd..

What is the FDA product code for Accutorr 7/VS-900 Vital Signs Monitor?

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

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Related PubMed Literature

PMID: 41836285 A Case Study of AI-Enabled Software as a Medical Device Cleared by the FDA for Assessing Hemorrhage Risk Index (APPRAISE-HRI) after Trauma. NEJM AI (2025) PMID: 40085833 The Measurement of Vital Signs in Pediatric Patients by Lifelight Software in Comparison to the Standard of Care: Protocol for the VISION-Junior Observational Study. JMIR research protocols (2025)

Other Devices by Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.

K173369DC-30/DC-32/DC-28/DC-26/DC-25 Diagnostic Ultrasound System K171233Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound System K202785Resona R9,Resona R9 Exp,Resona R9 Pro,Resona R9S, Nuewa R9,Nuewa R9 Exp,Nuewa R9 Pro,Nuewa R9S,Resona 7,Resona 7CV,Resona 7EXP,Resona 7S, Resona 7OB,Resona 7PRO,Imagyn 7,Resona Y Diagnostic Ultrasound System K221267VS 8 Vital Signs Monitor, VS 8A Vital Signs Monitor, VS 9 Vital Signs Monitor K222754ViewMate Multi Ultrasound System

Related Devices (Code: MWI)

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Official Source

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