The following data is part of a premarket notification filed by General Electric Medical Systems Information Techn with the FDA for Icg Module.
| Device ID | K010164 |
| 510k Number | K010164 |
| Device Name: | ICG MODULE |
| Classification | Plethysmograph, Impedance |
| 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 | DSB |
| CFR Regulation Number | 870.2770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-01-18 |
| Decision Date | 2001-04-09 |