The following data is part of a premarket notification filed by General Electric Medical Systems Information Techn with the FDA for Impact.wf Mobile Waveform Receiving System.
| Device ID | K994430 |
| 510k Number | K994430 |
| Device Name: | IMPACT.WF MOBILE WAVEFORM RECEIVING SYSTEM |
| Classification | System, Network And Communication, Physiological Monitors |
| Applicant | GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN 8200 WEST TOWER AVE. Milwaukee, WI 53223 |
| Contact | Karen Webb |
| Correspondent | Karen Webb GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN 8200 WEST TOWER AVE. Milwaukee, WI 53223 |
| Product Code | MSX |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-12-29 |
| Decision Date | 2000-03-28 |
| Summary: | summary |