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 |