The following data is part of a premarket notification filed by Olympus Medical Systems Corp. with the FDA for Endoscopic Ultrasound Center Eu-y0008.
| Device ID | K130058 |
| 510k Number | K130058 |
| Device Name: | ENDOSCOPIC ULTRASOUND CENTER EU-Y0008 |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | OLYMPUS MEDICAL SYSTEMS CORP. REGULATORY AFFAIRS & QUALITY ASSURANCE 3500 CORPORATE PARKWAY Center Valley, PA 18034 -0610 |
| Contact | Daphney Germain-kolawole |
| Correspondent | Daphney Germain-kolawole OLYMPUS MEDICAL SYSTEMS CORP. REGULATORY AFFAIRS & QUALITY ASSURANCE 3500 CORPORATE PARKWAY Center Valley, PA 18034 -0610 |
| Product Code | IYN |
| Subsequent Product Code | ITX |
| Subsequent Product Code | IYO |
| Subsequent Product Code | ODG |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-01-09 |
| Decision Date | 2013-02-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04953170356797 | K130058 | 000 |
| 04953170343414 | K130058 | 000 |
| 04953170418006 | K130058 | 000 |
| 04953170343384 | K130058 | 000 |