The following data is part of a premarket notification filed by Ge Medical Systems Information Technologies, Inc with the FDA for Mac 5500 Hd, Mac 3500.
| Device ID | K110266 |
| 510k Number | K110266 |
| Device Name: | MAC 5500 HD, MAC 3500 |
| Classification | Electrocardiograph |
| Applicant | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC 9900 INOVATION DRIVE Wauwatosa, WI 53226 |
| Contact | Patricia Taige |
| Correspondent | Patricia Taige GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC 9900 INOVATION DRIVE 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 | 2011-01-28 |
| Decision Date | 2011-04-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682123112 | K110266 | 000 |
| 00840682112406 | K110266 | 000 |
| 00840682104838 | K110266 | 000 |
| 00840682104791 | K110266 | 000 |