The following data is part of a premarket notification filed by Olympus America, Inc. with the FDA for Olympus Um-s30-25r Ultrasonic Probe And Associated Ancillary Equipment For Bronchial Use.
| Device ID | K994106 |
| 510k Number | K994106 |
| Device Name: | OLYMPUS UM-S30-25R ULTRASONIC PROBE AND ASSOCIATED ANCILLARY EQUIPMENT FOR BRONCHIAL USE |
| Classification | Transducer, Ultrasonic, Diagnostic |
| Applicant | OLYMPUS AMERICA, INC. TWO CORPORATE CENTER DR. Melville, NY 11747 -3157 |
| Contact | Laura Storms- Tyler |
| Correspondent | Laura Storms- Tyler OLYMPUS AMERICA, INC. TWO CORPORATE CENTER DR. Melville, NY 11747 -3157 |
| Product Code | ITX |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-12-06 |
| Decision Date | 2000-06-02 |
| Summary: | summary |