The following data is part of a premarket notification filed by Olympus Corp. with the FDA for Endoscopic Ultrasound System Type 20.
| Device ID | K926514 |
| 510k Number | K926514 |
| Device Name: | ENDOSCOPIC ULTRASOUND SYSTEM TYPE 20 |
| Classification | Endoscopic Ultrasound System, Gastroenterology-urology |
| Applicant | OLYMPUS CORP. 4 NEVADA DR. Lake Success, NY 11042 |
| Contact | Barry E Sands |
| Correspondent | Barry E Sands OLYMPUS CORP. 4 NEVADA DR. Lake Success, NY 11042 |
| Product Code | ODG |
| Subsequent Product Code | FDF |
| Subsequent Product Code | FDS |
| Subsequent Product Code | FDT |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-12-30 |
| Decision Date | 1993-08-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04953170368523 | K926514 | 000 |
| 04953170064012 | K926514 | 000 |
| 04953170053870 | K926514 | 000 |
| 04953170061837 | K926514 | 000 |
| 04953170062841 | K926514 | 000 |
| 04953170286384 | K926514 | 000 |
| 04953170355721 | K926514 | 000 |
| 04953170355738 | K926514 | 000 |
| 04953170368509 | K926514 | 000 |
| 04953170063749 | K926514 | 000 |