The following data is part of a premarket notification filed by Ge Medical Systems, Llc with the FDA for Critical Care Suite With Endotracheal Tube Positing Ai Algorithm.
| Device ID | K211161 |
| 510k Number | K211161 |
| Device Name: | Critical Care Suite With Endotracheal Tube Positing AI Algorithm |
| Classification | Automated Radiological Image Processing Software |
| Applicant | GE Medical Systems, LLC 3000 N. Grandview Blvd Waukesha, WI 53188 |
| Contact | Chris Paulik |
| Correspondent | Chris Paulik GE Medical Systems, LLC 3000 N. Grandview Blvd Waukesha, WI 53188 |
| Product Code | QIH |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-04-19 |
| Decision Date | 2021-10-29 |