The following data is part of a premarket notification filed by General Electric Medical Systems Information Techn with the FDA for Solar Spo2 Module With Masimo Set.
| Device ID | K002957 |
| 510k Number | K002957 |
| Device Name: | SOLAR SPO2 MODULE WITH MASIMO SET |
| Classification | Oximeter |
| Applicant | GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN 8200 WEST TOWER AVE. Milwaukee, WI 53223 |
| Contact | David Wahlig |
| Correspondent | David Wahlig GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN 8200 WEST TOWER AVE. Milwaukee, WI 53223 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-09-22 |
| Decision Date | 2000-10-18 |