The following data is part of a premarket notification filed by Olympus America, Inc. with the FDA for Olympus Eu-m60 Eus Exera Endoscopic Ultrasound Ctr, Eus Exera Ultrasonic Gastrovideoscope Olympus Gf Type Um 160,.
| Device ID | K011886 |
| 510k Number | K011886 |
| Device Name: | OLYMPUS EU-M60 EUS EXERA ENDOSCOPIC ULTRASOUND CTR, EUS EXERA ULTRASONIC GASTROVIDEOSCOPE OLYMPUS GF TYPE UM 160, |
| Classification | Endoscopic Ultrasound System, Gastroenterology-urology |
| Applicant | OLYMPUS AMERICA, INC. TWO CORPORATE CENTER DR. Melville, NY 11747 -3157 |
| Contact | Laura Storms-tyler |
| Correspondent | Laura Storms-tyler OLYMPUS AMERICA, INC. TWO CORPORATE CENTER DR. Melville, NY 11747 -3157 |
| Product Code | ODG |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-06-15 |
| Decision Date | 2001-08-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04953170368462 | K011886 | 000 |
| 04953170136559 | K011886 | 000 |
| 04953170136566 | K011886 | 000 |
| 04953170136573 | K011886 | 000 |
| 04953170136603 | K011886 | 000 |
| 04953170143649 | K011886 | 000 |
| 04953170143663 | K011886 | 000 |
| 04953170181733 | K011886 | 000 |
| 04953170311192 | K011886 | 000 |
| 04953170355684 | K011886 | 000 |
| 04953170355806 | K011886 | 000 |
| 04953170355813 | K011886 | 000 |
| 04953170355844 | K011886 | 000 |
| 04953170355851 | K011886 | 000 |
| 04953170356155 | K011886 | 000 |
| 04953170368431 | K011886 | 000 |
| 04953170368448 | K011886 | 000 |
| 04953170228971 | K011886 | 000 |