The following data is part of a premarket notification filed by Biobot Surgical Pte Ltd with the FDA for Isr'obot Mona Lisa.
| Device ID | K130944 |
| 510k Number | K130944 |
| Device Name: | ISR'OBOT MONA LISA |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | BIOBOT SURGICAL PTE LTD 20 MAXWELL ROAD, #09-17, MAXWELL HOUSE Singapore, SG 069113 |
| Contact | John Baby |
| Correspondent | John Baby BIOBOT SURGICAL PTE LTD 20 MAXWELL ROAD, #09-17, MAXWELL HOUSE Singapore, SG 069113 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-04-04 |
| Decision Date | 2013-06-07 |
| Summary: | summary |