The following data is part of a premarket notification filed by Biobot Surgical Pte Ltd with the FDA for Isrobot Mona Lisa.
| Device ID | K111347 |
| 510k Number | K111347 |
| Device Name: | ISROBOT MONA LISA |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | BIOBOT SURGICAL PTE LTD 901 KING ST SUITE 200 Alexandria, VA 22314 |
| Contact | Cherita James |
| Correspondent | Cherita James BIOBOT SURGICAL PTE LTD 901 KING ST SUITE 200 Alexandria, VA 22314 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-05-13 |
| Decision Date | 2011-08-12 |
| Summary: | summary |