The following data is part of a premarket notification filed by General Electric Medical Systems Information Techn with the FDA for Seer Light Compact Digital Holter Recorder.
| Device ID | K021470 |
| 510k Number | K021470 |
| Device Name: | SEER LIGHT COMPACT DIGITAL HOLTER RECORDER |
| Classification | Electrocardiograph, Ambulatory (without Analysis) |
| Applicant | GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN 8200 WEST TOWER AVE. Milwaukee, WI 53223 |
| Contact | Lisa Lee Michels |
| Correspondent | Lisa Lee Michels GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN 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 | 2002-05-08 |
| Decision Date | 2002-11-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04987382233966 | K021470 | 000 |
| 04987382233959 | K021470 | 000 |
| 04987382233942 | K021470 | 000 |
| 04987382233935 | K021470 | 000 |
| 04987382233928 | K021470 | 000 |
| 04987382233911 | K021470 | 000 |
| 04987382233904 | K021470 | 000 |
| 04987382233898 | K021470 | 000 |