The following data is part of a premarket notification filed by Ge Medical Systems Information Technologies, Inc with the FDA for Mac 600 Resting Ecg Analysis System.
| Device ID | K103765 |
| 510k Number | K103765 |
| Device Name: | MAC 600 RESTING ECG ANALYSIS SYSTEM |
| Classification | Electrocardiograph |
| Applicant | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC 9900 INOVATION DRIVE Wauwatosa, WI 53226 |
| Contact | Joe Lucas |
| Correspondent | Joe Lucas GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC 9900 INOVATION 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 | 2010-12-23 |
| Decision Date | 2011-05-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682134859 | K103765 | 000 |