The following data is part of a premarket notification filed by Biobot Surgical Pte Ltd with the FDA for Isr'obot Mona Lisa 1.0.
| Device ID | K203659 |
| 510k Number | K203659 |
| Device Name: | ISR'obot Mona Lisa 1.0 |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | Biobot Surgical Pte Ltd 2 Woodlands Spectrum L, #03-10 Woodlands Sector L Singapore, SG 738068 |
| Contact | Lim Yan Shin |
| Correspondent | Lim Yan Shin Biobot Surgical Pte Ltd 2 Woodlands Spectrum L, #03-10 Woodlands Sector L Singapore, SG 738068 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-12-15 |
| Decision Date | 2021-07-08 |