The following data is part of a premarket notification filed by Olympus Medical Systems Corporation with the FDA for Modification To Olympus Integrated Endosurgery System Endoalpha (control Unit For Endosurgery Uces-2) Software Version 3.
| Device ID | K051613 |
| 510k Number | K051613 |
| Device Name: | MODIFICATION TO OLYMPUS INTEGRATED ENDOSURGERY SYSTEM ENDOALPHA (CONTROL UNIT FOR ENDOSURGERY UCES-2) SOFTWARE VERSION 3 |
| Classification | Endoscopic Central Control Unit |
| Applicant | OLYMPUS MEDICAL SYSTEMS CORPORATION TWO CORPORATE CENTER DR. Melville, NY 11747 -9058 |
| Contact | Laura Storms-tyler |
| Correspondent | Laura Storms-tyler OLYMPUS MEDICAL SYSTEMS CORPORATION TWO CORPORATE CENTER DR. Melville, NY 11747 -9058 |
| Product Code | ODA |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-06-17 |
| Decision Date | 2005-08-15 |
| Summary: | summary |