The following data is part of a premarket notification filed by Broncus Technologies, Inc. with the FDA for Yield Mini Doppler System.
| Device ID | K090743 |
| 510k Number | K090743 |
| Device Name: | YIELD MINI DOPPLER SYSTEM |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | BRONCUS TECHNOLOGIES, INC. 1400N SHORELINE BLVD. BLDG. A, SUITE 8 Mountain View, CA 94043 |
| Contact | Nancy Isaac |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | IYN |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2009-03-20 |
| Decision Date | 2009-04-03 |
| Summary: | summary |