Device Classification Name |
System, Imaging, Pulsed Echo, Ultrasonic
|
510(k) Number |
K043275 |
Device Name |
OLYMPUS EU-M60 EUS EXERA ENDOSCOPIC ULTRASOUND CENTER |
Applicant |
OLYMPUS MEDICAL SYSTEMS CORPORATION |
TWO CORPORATE CENTER DR. |
MELVILLE,
NY
11747 -9058
|
|
Applicant Contact |
LAURA STORMS-TYLER |
Correspondent |
ENTELA, INC. |
3033 MADISON AVENUE, SE |
GRAND RAPIDS,
MI
49548
|
|
Correspondent Contact |
NED DEVINE |
Regulation Number | 892.1560
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 11/26/2004 |
Decision Date | 12/09/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|