Device Classification Name |
Ultrasound Bronchoscope
|
510(k) Number |
K021204 |
Device Name |
OLYMPUS BF TYPE UM40 |
Applicant |
OLYMPUS OPTICAL CO., LTD. |
TWO CORPORATE CENTER DR. |
MELVILLE,
NY
11747 -3157
|
|
Applicant Contact |
LAURA STORMS-TYLER |
Correspondent |
INTERTEK TESTING SERVICES |
2307 EAST AURORA ROAD |
UNIT B7 |
TWINSBURG,
OH
44087
|
|
Correspondent Contact |
DERWYN REUBER |
Regulation Number | 892.1550
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 04/16/2002 |
Decision Date | 05/01/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|