BBS REVOLUTION
System, Imaging, Pulsed Echo, Ultrasonic
DBMEDx INC.
The following data is part of a premarket notification filed by Dbmedx Inc. with the FDA for Bbs Revolution.
Pre-market Notification Details
| Device ID | K142329 |
| 510k Number | K142329 |
| Device Name: | BBS REVOLUTION |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | dBMEDx INC. 13 BLUE GROUSE RIDGE ROAD Littleton, CO 80127 |
| Contact | Dave Shine |
| Correspondent | Kevin Walls REGULATORY INSIGHT, INC. 33 GOLDEN EAGLE LANE Littleton, CO 80127 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-08-20 |
| Decision Date | 2014-12-15 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00869209000231 | K142329 | 000 |
| 00869209000224 | K142329 | 000 |
| 00869209000200 | K142329 | 000 |
| 00860001971439 | K142329 | 000 |
Trademark Results [BBS REVOLUTION]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BBS REVOLUTION 98753623 not registered Live/Pending |
dBMEDx Inc. 2024-09-16 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.