K103802 is an FDA 510(k) clearance for the TRUSIGNAL R SPO2 PEDITIP 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 August 2, 2011, 217 days after receiving the submission on December 28, 2010.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 870.2700.
| 510(k) Number | K103802 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 28, 2010 |
| Decision Date | August 02, 2011 |
| Days to Decision | 217 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | DQA — Oximeter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2700 |