The following data is part of a premarket notification filed by Smith & Nephew with the FDA for Intellio Tablet Application.
| Device ID | K192876 |
| 510k Number | K192876 |
| Device Name: | INTELLIO Tablet Application |
| Classification | Endoscopic Central Control Unit |
| Applicant | Smith & Nephew 150 Minuteman Rd Andover, MA 01810 |
| Contact | Janice Haselton |
| Correspondent | Janice Haselton Smith & Nephew 150 Minuteman Rd Andover, MA 01810 |
| Product Code | ODA |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-10-08 |
| Decision Date | 2020-02-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885556778777 | K192876 | 000 |