The following data is part of a premarket notification filed by Broncus Technologies, Inc. with the FDA for Exhale Rf Probe.
Device ID | K011267 |
510k Number | K011267 |
Device Name: | EXHALE RF PROBE |
Classification | Bronchoscope (flexible Or Rigid) |
Applicant | BRONCUS TECHNOLOGIES, INC. 1400N SHORELINE BLVD. BLDG. A, SUITE 8 Mountain View, CA 94043 |
Contact | Tim R Williams |
Product Code | EOQ |
CFR Regulation Number | 874.4680 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2001-04-26 |
Decision Date | 2001-05-08 |