Device Classification Name |
transducer, ultrasonic, diagnostic
|
510(k) Number |
K011314 |
Device Name |
OLYMPUS GF UC140P-AL5 ULTRASONIC ENDOSCOPE WITH ALOKA SSD-5500 ULTRASOUND SYSTEM |
Applicant |
ALOKA CO., LTD. |
10 FAIRFIELD BLVD. |
WALLINGFORD,
CT
06492
|
|
Applicant Contact |
KELVIN BURROUGHS |
Correspondent |
INTERTEK TESTING SERVICES |
2307 EAST AURORA ROAD |
UNIT B7 |
TWINSBURG,
OH
44087
|
|
Correspondent Contact |
PAT PALADINO |
Regulation Number | 892.1570
|
Classification Product Code |
|
Date Received | 04/30/2001 |
Decision Date | 05/15/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|