The following data is part of a premarket notification filed by Olympus America, Inc. with the FDA for Olympus Eu-m30 Endoscopic Ultrasound Center.
| Device ID | K951994 |
| 510k Number | K951994 |
| Device Name: | OLYMPUS EU-M30 ENDOSCOPIC ULTRASOUND CENTER |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | OLYMPUS AMERICA, INC. 4 NEVADA DR. Lake Success, NY 11042 -1179 |
| Contact | Barry E Sands |
| Correspondent | Barry E Sands OLYMPUS AMERICA, INC. 4 NEVADA DR. Lake Success, NY 11042 -1179 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-04-28 |
| Decision Date | 1996-04-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04953170355905 | K951994 | 000 |
| 04953170305528 | K951994 | 000 |
| 04953170064142 | K951994 | 000 |
| 04953170056871 | K951994 | 000 |
| 04953170026676 | K951994 | 000 |