The following data is part of a premarket notification filed by Broncus Technologies, Inc. with the FDA for Lungpoint Virtual Bronchoscopic Navigation Vbn System.
Device ID | K091160 |
510k Number | K091160 |
Device Name: | LUNGPOINT VIRTUAL BRONCHOSCOPIC NAVIGATION VBN SYSTEM |
Classification | System, Image Processing, Radiological |
Applicant | BRONCUS TECHNOLOGIES, INC. 1400 N. SHORELINE BLVD. BLDG A SUITE 8 Mountain Veiw, CA 94043 |
Contact | Mahtab Fatemi |
Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
Product Code | LLZ |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2009-04-21 |
Decision Date | 2009-05-05 |
Summary: | summary |