Device Classification Name |
Oximeter
|
510(k) Number |
K151024 |
Device Name |
Finger Type Pulse Oximeter |
Applicant |
TAIDOC TECHNOLOGY CORPORATION |
6F, NO. 127, WUGONG 2ND RD., WUGU DISTRICT |
NEW TAIPEI CITY,
TW
24888
|
|
Applicant Contact |
C. W. CHEN |
Correspondent |
TAIDOC TECHNOLOGY CORPORATION |
6F, NO. 127, WUGONG 2ND RD |
WUGU DISTRICT |
NEW TAIPEI CITY,
TW
24888
|
|
Correspondent Contact |
SHARON PENG |
Regulation Number | 870.2700
|
Classification Product Code |
|
Date Received | 04/16/2015 |
Decision Date | 03/02/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|