The following data is part of a premarket notification filed by Broncus Technologies, Inc. with the FDA for Exhale Doppler System.
| Device ID | K010649 |
| 510k Number | K010649 |
| Device Name: | EXHALE DOPPLER SYSTEM |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | BRONCUS TECHNOLOGIES, INC. 1400N SHORELINE BLVD. BLDG. A, SUITE 8 Mountain View, CA 94043 |
| Contact | Timothy R Williams |
| Correspondent | Mark Job TUV PRODUCT SERVICE, INC. 1775 OLD HIGHWAY 8 New Brighton, MN 55112 -1891 |
| Product Code | IYN |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2001-03-05 |
| Decision Date | 2001-03-20 |