The following data is part of a premarket notification filed by Olympus America, Inc. with the FDA for Olympus Ultrasonic Probes.
| Device ID | K944610 |
| 510k Number | K944610 |
| Device Name: | OLYMPUS ULTRASONIC PROBES |
| Classification | Transducer, Ultrasonic, Diagnostic |
| 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 | ITX |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-09-19 |
| Decision Date | 1995-04-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04953170368585 | K944610 | 000 |
| 04953170053573 | K944610 | 000 |
| 04953170053900 | K944610 | 000 |
| 04953170062476 | K944610 | 000 |
| 04953170062483 | K944610 | 000 |
| 04953170062490 | K944610 | 000 |
| 04953170063947 | K944610 | 000 |
| 04953170065385 | K944610 | 000 |
| 04953170078682 | K944610 | 000 |
| 04953170368424 | K944610 | 000 |
| 04953170368486 | K944610 | 000 |
| 04953170368493 | K944610 | 000 |
| 04953170368479 | K944610 | 000 |