Device Classification Name |
oximeter
|
510(k) Number |
K122927 |
Device Name |
OXICARE FINGERTIP PULSE OXIMETER |
Applicant |
DELBIO INCORPORATED |
3F & 6F, NO 252 SHANGYING ROAD |
TAOYUAN COUNTY |
GUISHAN INDUSTRIAL ZONE,
TW
33341
|
|
Applicant Contact |
NICKY PAN |
Correspondent |
DELBIO INCORPORATED |
3F & 6F, NO 252 SHANGYING ROAD |
TAOYUAN COUNTY |
GUISHAN INDUSTRIAL ZONE,
TW
33341
|
|
Correspondent Contact |
NICKY PAN |
Regulation Number | 870.2700
|
Classification Product Code |
|
Date Received | 09/24/2012 |
Decision Date | 12/20/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Anesthesiology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|