Device Classification Name |
Oximeter, Ear
|
510(k) Number |
K010718 |
Device Name |
FLEXI-SITE SP02 EAR SENSOR |
Applicant |
EPIC MEDICAL EQUIPMENT SERVICES, INC. |
1800 10TH ST., SUITE 300 |
PLANO,
TX
75074
|
|
Applicant Contact |
KRISTA OAKES |
Correspondent |
EPIC MEDICAL EQUIPMENT SERVICES, INC. |
1800 10TH ST., SUITE 300 |
PLANO,
TX
75074
|
|
Correspondent Contact |
KRISTA OAKES |
Regulation Number | 870.2710
|
Classification Product Code |
|
Date Received | 03/12/2001 |
Decision Date | 03/23/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Anesthesiology
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|