The following data is part of a premarket notification filed by Dornoch Medical Systems with the FDA for Intellicarttm System.
| Device ID | K190789 |
| 510k Number | K190789 |
| Device Name: | IntelliCartTM System |
| Classification | Apparatus, Suction, Ward Use, Portable, Ac-powered |
| Applicant | Dornoch Medical Systems 200 North West Parkway Riverside, MO 64150 |
| Contact | Larry Smith |
| Correspondent | Michael Wolford Dornoch Medical Systems 200 North West Parkway Riverside, MO 64150 |
| Product Code | JCX |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-03-27 |
| Decision Date | 2019-04-24 |