The following data is part of a premarket notification filed by Ge Medical Systems Information Technologies with the FDA for Mac 1600 Ecg Analysis System.
| Device ID | K081437 |
| 510k Number | K081437 |
| Device Name: | MAC 1600 ECG ANALYSIS SYSTEM |
| Classification | Electrocardiograph |
| Applicant | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES 9900 INNOVATION DR. RP-2122 Wauwatosa, WI 53226 |
| Contact | Margaret Mucha |
| Correspondent | Margaret Mucha GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES 9900 INNOVATION DR. RP-2122 Wauwatosa, WI 53226 |
| Product Code | DPS |
| Subsequent Product Code | DQK |
| Subsequent Product Code | DXH |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-05-22 |
| Decision Date | 2008-07-15 |
| Summary: | summary |