The following data is part of a premarket notification filed by Aloka Co., Ltd. with the FDA for Olympus Gf Uc140p-al5 Ultrasonic Endoscope With Aloka Ssd-5500 Ultrasound System.
| Device ID | K011314 |
| 510k Number | K011314 |
| Device Name: | OLYMPUS GF UC140P-AL5 ULTRASONIC ENDOSCOPE WITH ALOKA SSD-5500 ULTRASOUND SYSTEM |
| Classification | Transducer, Ultrasonic, Diagnostic |
| Applicant | ALOKA CO., LTD. 10 FAIRFIELD BLVD. Wallingford, CT 06492 |
| Contact | Kelvin Burroughs |
| Correspondent | Pat Paladino INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | ITX |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2001-04-30 |
| Decision Date | 2001-05-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04953170356322 | K011314 | 000 |
| 04953170355448 | K011314 | 000 |
| 04953170355431 | K011314 | 000 |
| 04953170341748 | K011314 | 000 |
| 04953170167638 | K011314 | 000 |
| 04953170062803 | K011314 | 000 |
| 04953170062797 | K011314 | 000 |