Device Classification Name |
Oximeter
|
510(k) Number |
K113727 |
Device Name |
SHENZHEN MED-LINK PULSE OXIMETER PROBE |
Applicant |
SHENZHEN MED-LINK ELECTRONICS TECH CO., LTD. |
144 RESEARCH DRIVE |
HAMPTON,
VA
23666
|
|
Applicant Contact |
RHONDA ALEXANDER |
Correspondent |
SHENZHEN MED-LINK ELECTRONICS TECH CO., LTD. |
144 RESEARCH DRIVE |
HAMPTON,
VA
23666
|
|
Correspondent Contact |
RHONDA ALEXANDER |
Regulation Number | 870.2700
|
Classification Product Code |
|
Date Received | 12/19/2011 |
Decision Date | 03/21/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|