The following data is part of a premarket notification filed by Body Vision Medical Ltd. with the FDA for Lungvision Tool.
| Device ID | K172955 |
| 510k Number | K172955 |
| Device Name: | LungVision Tool |
| Classification | Bronchoscope (flexible Or Rigid) |
| Applicant | Body Vision Medical Ltd. 34 SOKOLOV ST. Ramat Hasharon, IL |
| Contact | Dorian Averbuch |
| Correspondent | Paul Dryden ProMedic, LLC 131 Bay Point Dr. NE St. Petersburg, FL 33704 |
| Product Code | EOQ |
| CFR Regulation Number | 874.4680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-26 |
| Decision Date | 2018-04-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290017652023 | K172955 | 000 |
| 07290017652153 | K172955 | 000 |
| 07290017652160 | K172955 | 000 |
| 07290017652177 | K172955 | 000 |
| 07290017652184 | K172955 | 000 |
| 07290017652191 | K172955 | 000 |
| 07290017652115 | K172955 | 000 |
| 07290017652122 | K172955 | 000 |
| 07290017652139 | K172955 | 000 |
| 07290017652146 | K172955 | 000 |
| 07290017652092 | K172955 | 000 |
| 07290017652061 | K172955 | 000 |
| 07290017652078 | K172955 | 000 |
| 07290017652047 | K172955 | 000 |
| 07290017652016 | K172955 | 000 |
| 07290017652108 | K172955 | 000 |