K093881 is an FDA 510(k) clearance for the TRUSIGNAL SPO2 FINGER SENSOR, TRUSIGNAL SPO2 EAR SENSOR, TRUSIGNAL SPO2 WRAP SENSOR. This device is classified as a Oximeter (Class II - Special Controls, product code DQA).
Submitted by GE Healthcare Finland Oy (Helsinki, FI). The FDA issued a Cleared decision on March 12, 2010, 84 days after receiving the submission on December 18, 2009.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 870.2700.
| 510(k) Number | K093881 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 18, 2009 |
| Decision Date | March 12, 2010 |
| Days to Decision | 84 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 |