The following data is part of a premarket notification filed by General Electric Medical Systems Information Techn with the FDA for Mars Unity Workstation With Heart Rate Variability (hrv) Option.
| Device ID | K991786 |
| 510k Number | K991786 |
| Device Name: | MARS UNITY WORKSTATION WITH HEART RATE VARIABILITY (HRV) OPTION |
| Classification | Electrocardiograph |
| Applicant | GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN 8200 WEST TOWER AVE. Milwaukee, WI 53223 |
| Contact | Laura L Mccomis |
| Correspondent | Laura L Mccomis GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN 8200 WEST TOWER AVE. Milwaukee, WI 53223 |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-05-25 |
| Decision Date | 1999-11-18 |
| Summary: | summary |