The following data is part of a premarket notification filed by Ge Healthcare Systems Information Technologies with the FDA for Modification To: Mac 5500 Resting Ecg Analysis System.
| Device ID | K073625 |
| 510k Number | K073625 |
| Device Name: | MODIFICATION TO: MAC 5500 RESTING ECG ANALYSIS SYSTEM |
| Classification | Electrocardiograph |
| Applicant | GE HEALTHCARE SYSTEMS INFORMATION TECHNOLOGIES 9900 Innovation Drive Wauwatosa, WI 53226 |
| Contact | Margaret Mucha |
| Correspondent | Margaret Mucha GE HEALTHCARE SYSTEMS INFORMATION TECHNOLOGIES 9900 Innovation Drive Wauwatosa, WI 53226 |
| Product Code | DPS |
| Subsequent Product Code | DHX |
| Subsequent Product Code | DQK |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-12-26 |
| Decision Date | 2008-01-25 |
| Summary: | summary |