Device Classification Name |
Oximeter
|
510(k) Number |
K011320 |
Device Name |
ETG-100 OPTICAL ENCEPHALOGRAPHY SYSTEM |
Applicant |
HITACHI MEDICAL SYSTEMS AMERICA, INC. |
1959 SUMMIT COMMERCE PARK |
TWINSBURG,
OH
44087
|
|
Applicant Contact |
ROBERT H MCCARTHY |
Correspondent |
HITACHI MEDICAL SYSTEMS AMERICA, INC. |
1959 SUMMIT COMMERCE PARK |
TWINSBURG,
OH
44087
|
|
Correspondent Contact |
ROBERT H MCCARTHY |
Regulation Number | 870.2700
|
Classification Product Code |
|
Date Received | 05/01/2001 |
Decision Date | 08/09/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|