The following data is part of a premarket notification filed by Dornoch Medical Systems with the FDA for Intellicart System.
Device ID | K172481 |
510k Number | K172481 |
Device Name: | IntelliCart 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 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 | 2017-08-16 |
Decision Date | 2017-09-14 |
Summary: | summary |