The following data is part of a premarket notification filed by Ge Medical Systems China Co., Ltd. with the FDA for Mac 800 Resting Ecg Analysis System.
| Device ID | K142288 |
| 510k Number | K142288 |
| Device Name: | MAC 800 Resting ECG Analysis System |
| Classification | Electrocardiograph |
| Applicant | GE MEDICAL SYSTEMS CHINA CO., LTD. NO. 19 CHANGJIANG ROAD, NATIONAL HI-TECH DEV. ZONE NATIONAL HI-TECH DEV. ZONE Wuxi, CN 214028 |
| Contact | Sun Yanli |
| Correspondent | Kristin Pabst GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES 9900 WEST INNOVATION DR. Wauwatosa, WI 53226 |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-08-18 |
| Decision Date | 2014-12-03 |
| Summary: | summary |