The following data is part of a premarket notification filed by Dornoch Medical Systems with the FDA for Intellicarttm System.
| Device ID | K162421 |
| 510k Number | K162421 |
| Device Name: | IntelliCartTM System |
| Classification | Apparatus, Suction, Ward Use, Portable, Ac-powered |
| Applicant | DORNOCH MEDICAL SYSTEMS 200 NW PARKWAY Riverside, MO 64150 |
| Contact | Larry Smith |
| Correspondent | Michael Wolford DORNOCH MEDICAL SYSTEMS 200 NW 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 | 2016-08-30 |
| Decision Date | 2016-12-21 |
| Summary: | summary |