The following data is part of a premarket notification filed by The Olympus Optical Co. with the FDA for Olympus Um 2r/3r Ultrasonic Probe And Associated Ancillary Equipment For Female Reproductive Tract.
| Device ID | K001203 |
| 510k Number | K001203 |
| Device Name: | OLYMPUS UM 2R/3R ULTRASONIC PROBE AND ASSOCIATED ANCILLARY EQUIPMENT FOR FEMALE REPRODUCTIVE TRACT |
| Classification | Transducer, Ultrasonic, Diagnostic |
| Applicant | THE OLYMPUS OPTICAL CO. TWO CORPORATE DR. Melville, NY 11747 |
| Contact | Laura Storms-tyler |
| Correspondent | Laura Storms-tyler THE OLYMPUS OPTICAL CO. TWO CORPORATE DR. 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 | 2000-04-13 |
| Decision Date | 2000-05-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04953170368592 | K001203 | 000 |
| 04953170368578 | K001203 | 000 |
| 04953170368561 | K001203 | 000 |
| 04953170368554 | K001203 | 000 |
| 04953170078705 | K001203 | 000 |
| 04953170078668 | K001203 | 000 |
| 04953170063213 | K001203 | 000 |
| 04953170063206 | K001203 | 000 |