K081870 is an FDA 510(k) clearance for the MASIMO COMPATIBLE SATURATION MODULE, E-MASIMO. This device is classified as a Oximeter (Class II - Special Controls, product code DQA).
Submitted by GE Healthcare Finland Oy (Milwaukee, US). The FDA issued a Cleared decision on July 31, 2008, 30 days after receiving the submission on July 1, 2008.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 870.2700.
| 510(k) Number | K081870 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 01, 2008 |
| Decision Date | July 31, 2008 |
| Days to Decision | 30 days |
| Submission Type | Special |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | DQA — Oximeter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2700 |