The following data is part of a premarket notification filed by Ge Medical Systems Information Technologies with the FDA for Seer Light Extend Compact Digital Holter System.
| Device ID | K050731 |
| 510k Number | K050731 |
| Device Name: | SEER LIGHT EXTEND COMPACT DIGITAL HOLTER SYSTEM |
| Classification | Electrocardiograph, Ambulatory (without Analysis) |
| Applicant | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES 8200 WEST TOWER AVE. Milwaukee, WI 53223 |
| Contact | Lisa M Baumhardt |
| Correspondent | Lisa M Baumhardt GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES 8200 WEST TOWER AVE. Milwaukee, WI 53223 |
| Product Code | MWJ |
| CFR Regulation Number | 870.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-03-21 |
| Decision Date | 2005-05-19 |
| Summary: | summary |