Device Classification Name |
oximeter
|
510(k) Number |
K133090 |
Device Name |
OXICARE FINGERTIP PULSE OXIMETER |
Applicant |
DELBIO INCORPORATION |
4405 CUSHING PKWY. |
FREMONT CITY,
CA
94538
|
|
Applicant Contact |
ERICA LI |
Correspondent |
DELBIO INCORPORATION |
4405 CUSHING PKWY. |
FREMONT CITY,
CA
94538
|
|
Correspondent Contact |
ERICA LI |
Regulation Number | 870.2700
|
Classification Product Code |
|
Date Received | 09/30/2013 |
Decision Date | 02/28/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Anesthesiology
|
Statement |
Statement
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|