510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.

Great Neck, NY, US

Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. appears in FDA device records in Great Neck, NY. FDA records list 9 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.

FDA records held for this company

510(k) clearances
9
PMA records
0
Recall records
0
Registered establishments
0

510(k) clearance history

FDA records hold 9 510(k) clearances for Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. between 2012 and 2022. The busiest year on record is 2017, with 3. The most recent is 2022, with 2.

Clearances by year, as a table
510(k) clearance decisions for Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd., by decision year
YearClearances
20121
20142
20173
20211
20222
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K221267VS 8 Vital Signs Monitor, VS 8A Vital Signs Monitor, VS 9 Vital Signs MonitorMWISubstantially Equivalent
K222754ViewMate Multi Ultrasound SystemIYNSubstantially Equivalent
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 SystemIYNSubstantially Equivalent
K173369DC-30/DC-32/DC-28/DC-26/DC-25 Diagnostic Ultrasound SystemIYNSubstantially Equivalent
K171233Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound SystemIYNSubstantially Equivalent
K170712Accutorr 7/VS-900 Vital Signs MonitorMWISubstantially Equivalent
K143195Passport Series Patient Monitors (including Passport 17M, Passport 12M and T1)MHXSubstantially Equivalent
K132036HYPERVISOR CENTRAL MONITORING SYSTEM (INCLUDING TELEMETRY MONITORING SYSTEM, TMS-6016)MSXSubstantially Equivalent
K113632DP-5 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM DP-7 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEMIYOSubstantially Equivalent

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain