The following data is part of a premarket notification filed by Ge Medical Systems Information Technologies with the FDA for Qt Guard Plus Analysis System.
| Device ID | K120770 |
| 510k Number | K120770 |
| Device Name: | QT GUARD PLUS ANALYSIS SYSTEM |
| Classification | Electrocardiograph |
| Applicant | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES 9900 Innovation Drive Wauwatosa, WI 53226 |
| Contact | Kristin Pabst |
| Correspondent | Kristin Pabst GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES 9900 Innovation Drive Wauwatosa, WI 53226 |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-03-14 |
| Decision Date | 2012-12-06 |
| Summary: | summary |