The following data is part of a premarket notification filed by Biobot Surgical Pte Ltd with the FDA for Isr’obot Mona Lisa 2.0.
| Device ID | K213411 |
| 510k Number | K213411 |
| Device Name: | ISR’obot Mona Lisa 2.0 |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | Biobot Surgical Pte Ltd 79 Ayer Rajah Crescent, #04-05 Singapore, SG 139955 |
| Contact | Lim Yan Shin |
| Correspondent | Lim Yan Shin Biobot Surgical Pte Ltd 79 Ayer Rajah Crescent, #04-05 Singapore, SG 139955 |
| Product Code | IYO |
| Subsequent Product Code | ITX |
| Subsequent Product Code | LLZ |
| Subsequent Product Code | OIJ |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-10-19 |
| Decision Date | 2021-12-22 |