510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Contec Medical Systems Co., Ltd.

Qinhuangdao Hebei, CN

CONTEC MEDICAL SYSTEMS CO., LTD appears in FDA device records in Qinhuangdao Hebei, CN. FDA records list 12 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
12
PMA records
0
Recall records
1
Registered establishments
1

510(k) clearance history

FDA records hold 12 510(k) clearances for Contec Medical Systems Co., Ltd. between 2011 and 2024. The busiest year on record is 2024, with 3. The most recent is 2024, with 3.

Clearances by year, as a table
510(k) clearance decisions for Contec Medical Systems Co., Ltd., by decision year
YearClearances
20111
20151
20161
20172
20181
20201
20211
20221
20243
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K232893Pocket Fetal Doppler (CONTEC 10D), Pocket Fetal Doppler (CONTEC 10E), Pocket Fetal Doppler (CONTEC 10F)KNGSubstantially Equivalent
K232895B-Ultrasound Diagnostic SystemIYOSubstantially Equivalent
K232908Color Doppler Ultrasound Diagnostic System (CMS1700B), Color Doppler Ultrasound Diagnostic System (CMS1700C)IYNSubstantially Equivalent
K220245Pocket Fetal Doppler (Models CONTEC10C and CONTEC10CL)KNGSubstantially Equivalent
K202757CONTEC08A Electronic Sphygmomanometer, CONTEC08C Electronic Sphygmomanometer, ABPM50 Automatic Blood Pressure MonitorDXNSubstantially Equivalent
K201980Infrared ThermometerFLLSubstantially Equivalent
K171360CONTEC™ ElectrocardiographDPSSubstantially Equivalent
K170856CMS600P2 B-Ultrasound Diagnostic SystemIYOSubstantially Equivalent
K170954Portable ECG MonitorDPSSubstantially Equivalent
K152863Portable ECG MonitorDPSSubstantially Equivalent
K141362PULSE OXIMETER CMS50EWDQASubstantially Equivalent
K110775ELECTRONIC SPHYGMOMANOMETERDXNSubstantially Equivalent

Registered establishments

FDA registered establishments for Contec Medical Systems Co., Ltd., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30069796783006979678CONTEC MEDICAL SYSTEMS CO., LTDNo.112 Qinhuang West Street, Qinhuangdao Hebei 066004 CN2026and 12 more, listed in full below

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-1764-2025CMS8000 Patient MonitorPatient monitor has nine identified cybersecurity vulnerabilities.Class IIOpen, Classified

Verification record

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