The following data is part of a premarket notification filed by Olympus Optical, Co. with the FDA for Olympus Um-2r/3r Ultrasonic Probes And Associated Ancillary Equipment (urinary Tract).
| Device ID | K982610 |
| 510k Number | K982610 |
| Device Name: | OLYMPUS UM-2R/3R ULTRASONIC PROBES AND ASSOCIATED ANCILLARY EQUIPMENT (URINARY TRACT) |
| Classification | Transducer, Ultrasonic, Diagnostic |
| Applicant | OLYMPUS OPTICAL, CO. 2 CORPORATE CENTER Melville, NY 11747 |
| Contact | Laura Storms-tyler |
| Correspondent | Laura Storms-tyler OLYMPUS OPTICAL, CO. 2 CORPORATE CENTER Melville, NY 11747 |
| Product Code | ITX |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-07-27 |
| Decision Date | 1998-11-16 |
| Summary: | summary |