Device Classification Name |
Oximeter
|
510(k) Number |
K990082 |
Device Name |
EPIC SPO2 FINGER SENSOR, MODEL E403-09, E412-09 AND EPIC OXIMETER CABLE, MODEL E710-09 |
Applicant |
EPIC MEDICAL EQUIPMENT SERVICES, INC. |
1800 10TH ST., SUITE 300 |
PLANO,
TX
75074
|
|
Applicant Contact |
JEFFREY SECUNDA |
Correspondent |
EPIC MEDICAL EQUIPMENT SERVICES, INC. |
1800 10TH ST., SUITE 300 |
PLANO,
TX
75074
|
|
Correspondent Contact |
JEFFREY SECUNDA |
Regulation Number | 870.2700
|
Classification Product Code |
|
Date Received | 01/11/1999 |
Decision Date | 04/09/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|