The following data is part of a premarket notification filed by Olympus Medical Systems Corporation with the FDA for Olympus Eu-m60 Eus Exera Endoscopic Ultrasound Center.
| Device ID | K043275 |
| 510k Number | K043275 |
| Device Name: | OLYMPUS EU-M60 EUS EXERA ENDOSCOPIC ULTRASOUND CENTER |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | OLYMPUS MEDICAL SYSTEMS CORPORATION TWO CORPORATE CENTER DR. Melville, NY 11747 -9058 |
| Contact | Laura Storms-tyler |
| Correspondent | Ned Devine ENTELA, INC. 3033 MADISON AVENUE, SE Grand Rapids, MI 49548 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2004-11-26 |
| Decision Date | 2004-12-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04953170355967 | K043275 | 000 |
| 04953170062148 | K043275 | 000 |
| 04953170062919 | K043275 | 000 |
| 04953170327209 | K043275 | 000 |
| 04953170327216 | K043275 | 000 |
| 04953170026485 | K043275 | 000 |
| 04953170026492 | K043275 | 000 |
| 04953170028359 | K043275 | 000 |
| 04953170028380 | K043275 | 000 |
| 04953170216992 | K043275 | 000 |
| 04953170304897 | K043275 | 000 |
| 04953170344312 | K043275 | 000 |
| 04953170355769 | K043275 | 000 |
| 04953170355776 | K043275 | 000 |
| 04953170062131 | K043275 | 000 |