The following data is part of a premarket notification filed by Olympus Medical Systems Corporation with the FDA for Olympus Xbf-uc180f-dt8 Ultrasonic Bronchofibervideoscope Used With Aloka Ssd-alpha 5/10 Ultrasound System.
| Device ID | K070983 |
| 510k Number | K070983 |
| Device Name: | OLYMPUS XBF-UC180F-DT8 ULTRASONIC BRONCHOFIBERVIDEOSCOPE USED WITH ALOKA SSD-ALPHA 5/10 ULTRASOUND SYSTEM |
| Classification | Ultrasound Bronchoscope |
| Applicant | OLYMPUS MEDICAL SYSTEMS CORPORATION 3500 CORPORATE PARKWAY PO BOX 610 Center Valley, PA 18034 -0610 |
| Contact | Laura Storms-tyler |
| Correspondent | Laura Storms-tyler OLYMPUS MEDICAL SYSTEMS CORPORATION 3500 CORPORATE PARKWAY PO BOX 610 Center Valley, PA 18034 -0610 |
| Product Code | PSV |
| Subsequent Product Code | ITX |
| Subsequent Product Code | IYN |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-04-06 |
| Decision Date | 2007-07-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04953170356360 | K070983 | 000 |
| 04953170243226 | K070983 | 000 |
| 04953170243233 | K070983 | 000 |
| 04953170328442 | K070983 | 000 |
| 04953170341823 | K070983 | 000 |
| 04953170341830 | K070983 | 000 |
| 04953170355592 | K070983 | 000 |
| 04953170355608 | K070983 | 000 |
| 04953170355653 | K070983 | 000 |
| 04953170355660 | K070983 | 000 |
| 04953170355677 | K070983 | 000 |
| 04953170356353 | K070983 | 000 |
| 04953170233210 | K070983 | 000 |