Device Classification Name |
System, Nuclear Magnetic Resonance Imaging
|
510(k) Number |
K961174 |
Device Name |
ECG MONITOR MODEL DS-3130/3140 |
Applicant |
HITACHI MEDICAL SYSTEMS AMERICA, INC. |
1963 CASE PKWY. |
TWINSBURG,
OH
44087
|
|
Applicant Contact |
JAMES J ROGERS |
Correspondent |
HITACHI MEDICAL SYSTEMS AMERICA, INC. |
1963 CASE PKWY. |
TWINSBURG,
OH
44087
|
|
Correspondent Contact |
JAMES J ROGERS |
Regulation Number | 892.1000
|
Classification Product Code |
|
Date Received | 03/25/1996 |
Decision Date | 06/21/1996 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|