The following data is part of a premarket notification filed by Intelligent Endoscopy with the FDA for Smartband Emr Kit, Smartband Emr Pack, Smartsnare.
| Device ID | K190512 |
| 510k Number | K190512 |
| Device Name: | SmartBand EMR Kit, SmartBand EMR Pack, SmartSnare |
| Classification | Snare, Flexible |
| Applicant | Intelligent Endoscopy 4740 Commercial Park Ct, Suite 1 Clemmons, NC 27012 |
| Contact | Melissa Clark |
| Correspondent | Melissa Clark Intelligent Endoscopy 4740 Commercial Park Ct, Suite 1 Clemmons, NC 27012 |
| Product Code | FDI |
| CFR Regulation Number | 876.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-03-01 |
| Decision Date | 2019-11-22 |