Device Classification Name |
oximeter
|
510(k) Number |
K970098 |
Device Name |
E100 SERIES SPO2 SENSORS |
Applicant |
EPIC MEDICAL EQUIPMENT SERVICES, INC. |
4643 WESTGROVE |
DALLAS,
TX
75248
|
|
Applicant Contact |
JEFFREY SECUNDA |
Correspondent |
EPIC MEDICAL EQUIPMENT SERVICES, INC. |
4643 WESTGROVE |
DALLAS,
TX
75248
|
|
Correspondent Contact |
JEFFREY SECUNDA |
Regulation Number | 870.2700
|
Classification Product Code |
|
Date Received | 01/13/1997 |
Decision Date | 04/30/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Anesthesiology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|