The following data is part of a premarket notification filed by Biobot Surgical Pte Ltd with the FDA for Isr'obot Biopsy Kit.
| Device ID | K163502 |
| 510k Number | K163502 |
| Device Name: | ISR'obot Biopsy Kit |
| Classification | Transducer, Ultrasonic, Diagnostic |
| Applicant | Biobot Surgical Pte Ltd 79, Ayer Rajah Crescent, #04-05/06 Singapore, SG 139955 |
| Contact | Lai Chee Liew |
| Correspondent | Lai Chee Liew Biobot Surgical Pte Ltd 79, Ayer Rajah Crescent, #04-05/06 Singapore, SG 139955 |
| Product Code | ITX |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-12-14 |
| Decision Date | 2017-05-16 |
| Summary: | summary |