Device Classification Name |
cable, transducer and electrode, patient, (including connector)
|
510(k) Number |
K120010 |
Device Name |
CABLE/ LEAD-WIRE (ECG, EKG, SPO2 AND INVASIVE BLOOD PRESSURE) |
Applicant |
SHENZHEN MED-LINK ELECTRONICS TECH CO., LTD. |
INDUSTRIAL HUA WANG |
RD DALANG LONGHUA DIST |
SHENZHEN, GUANGDONG,
CN
518109
|
|
Applicant Contact |
MAOLIN YE |
Correspondent |
INTERTEK TESTING SERVICES |
2307 EAST AURORA ROAD |
UNIT B7 |
TWINSBURG,
OH
44087
|
|
Correspondent Contact |
BHAVESH V SHETH |
Regulation Number | 870.2900
|
Classification Product Code |
|
Date Received | 01/03/2012 |
Decision Date | 01/19/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|