The following data is part of a premarket notification filed by Broncus Medical Inc with the FDA for Lungpoint Atv Planning And Navigation Software.
Device ID | K133385 |
510k Number | K133385 |
Device Name: | LUNGPOINT ATV PLANNING AND NAVIGATION SOFTWARE |
Classification | System, Image Processing, Radiological |
Applicant | BRONCUS MEDICAL INC 1400 N. Shoreline Blvd., Bldg A, Suite 8 Mountain View, CA 94043 |
Contact | Robin Bush |
Correspondent | Robin Bush BRONCUS MEDICAL INC 1400 N. Shoreline Blvd., Bldg A, Suite 8 Mountain View, CA 94043 |
Product Code | LLZ |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-11-05 |
Decision Date | 2014-02-26 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00856571007104 | K133385 | 000 |
00856571007036 | K133385 | 000 |