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FDA 510(k)

VS 8 Vital Signs Monitor, VS 8A Vital Signs Monitor, VS 9 Vital Signs Monitor

K-Number: K221267 · 2022-12-15

ApplicantShenzhen Mindray Bio-Meidcal Electronics Co., Ltd.
Decision Date2022-12-15
Product CodeMWI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

VS 8 Vital Signs Monitor, VS 8A Vital Signs Monitor, VS 9 Vital Signs Monitor is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.. It received FDA 510(k) clearance on 2022-12-15 under 510(k) number K221267. 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 VS 8 Vital Signs Monitor, VS 8A Vital Signs Monitor, VS 9 Vital Signs Monitor?

VS 8 Vital Signs Monitor, VS 8A Vital Signs Monitor, VS 9 Vital Signs Monitor is a medical device that received FDA 510(k) clearance on 2022-12-15. The listed applicant is Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.. The 510(k) number is K221267.

When did VS 8 Vital Signs Monitor, VS 8A Vital Signs Monitor, VS 9 Vital Signs Monitor receive FDA 510(k) clearance?

VS 8 Vital Signs Monitor, VS 8A Vital Signs Monitor, VS 9 Vital Signs Monitor received FDA 510(k) clearance on 2022-12-15, under 510(k) number K221267.

Who is the listed applicant for VS 8 Vital Signs Monitor, VS 8A Vital Signs Monitor, VS 9 Vital Signs Monitor?

The FDA 510(k) record lists Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VS 8 Vital Signs Monitor, VS 8A Vital Signs Monitor, VS 9 Vital Signs Monitor?

The FDA product code for VS 8 Vital Signs Monitor, VS 8A Vital Signs Monitor, VS 9 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.

NCT04011163Vital Signs-Integrated Patient-Assisted Intravenous Opioid Analgesia for Post Surgical PainACTIVE_NOT_RECRUITINGNCT06238180Personalised Real-time Interoperable Sepsis Monitoring (PRISM)WITHDRAWNNCT06693817Advanced Wireless Sensors for Neonatal Care in the Delivery RoomRECRUITINGNCT06942338Comparative Evaluation of Body Temperature Measurement Using the CardioWatch 287-2 in an Intensive Care Setting.NOT_YET_RECRUITINGNCT07231653Home Monitoring Study for Surgical PatientsNOT_YET_RECRUITINGNCT07496346Integration of a Robotic Platform for Clinical Monitoring of Patients With Severe Acquired Brain Injury in High-Intensity Care UnitsNOT_YET_RECRUITING

Other records listing Shenzhen Mindray Bio-Meidcal 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.

K222754ViewMate Multi Ultrasound SystemK202785Resona 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 SystemK173369DC-30/DC-32/DC-28/DC-26/DC-25 Diagnostic Ultrasound SystemK171233Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound SystemK170712Accutorr 7/VS-900 Vital Signs Monitor

Related Devices (Code: MWI)

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.

K260438Vital Signs Monitor (CLEO2)Infinium Medical, Inc.K253417Masimo Root Monitoring SystemMasimo CorporationK253196Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400)Midmark CorporationK253436c-med0 alphaCosinuss GmbHK250135WAVE Clinical Platform (2.0.000)Baxter Healthcare Corp/ Excel MedicalK241766QMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid)Fysicon BV

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.

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