The following data is part of a premarket notification filed by Ge Healthcare Finland Oy with the FDA for Masimo Compatible Saturation Module, E-masimo.
| Device ID | K081870 |
| 510k Number | K081870 |
| Device Name: | MASIMO COMPATIBLE SATURATION MODULE, E-MASIMO |
| Classification | Oximeter |
| Applicant | GE HEALTHCARE FINLAND OY 8200 WEST TOWER AVENUE Milwaukee, WI 53223 |
| Contact | John Pendergast |
| Correspondent | John Pendergast GE HEALTHCARE FINLAND OY 8200 WEST TOWER AVENUE 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 | 2008-07-01 |
| Decision Date | 2008-07-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682104203 | K081870 | 000 |