CABLE/ LEAD-WIRE (ECG, EKG, SPO2 AND INVASIVE BLOOD PRESSURE)

Cable, Transducer And Electrode, Patient, (including Connector)

SHENZHEN MED-LINK ELECTRONICS TECH CO., LTD.

The following data is part of a premarket notification filed by Shenzhen Med-link Electronics Tech Co., Ltd. with the FDA for Cable/ Lead-wire (ecg, Ekg, Spo2 And Invasive Blood Pressure).

Pre-market Notification Details

• Device ID: K120010
• 510k Number: K120010
• Device Name: CABLE/ LEAD-WIRE (ECG, EKG, SPO2 AND INVASIVE BLOOD PRESSURE)
• Classification: Cable, Transducer And Electrode, Patient, (including Connector)
• Applicant: SHENZHEN MED-LINK ELECTRONICS TECH CO., LTD. INDUSTRIAL HUA WANG RD DALANG LONGHUA DIST Shenzhen, Guangdong, CN 518109
• Contact: Maolin Ye
• Correspondent: Bhavesh V Sheth; INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087
• Product Code: DSA
• CFR Regulation Number: 870.2900 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: Yes
• Combination Product: No
• Date Received: 2012-01-03
• Decision Date: 2012-01-19
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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