Submission Details
| 510(k) Number | K101871 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 06, 2010 |
| Decision Date | October 04, 2010 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
Cleared
Traditional
K101871 - TRUSIGNAL SPO2 FINGERTIP SENSOR
(FDA 510(k) Clearance)
Oct 2010
Decision
90d
Days
Class 2
Risk
K101871 is an FDA 510(k) clearance for the TRUSIGNAL SPO2 FINGERTIP SENSOR, a Oximeter (Class II — Special Controls, product code DQA), submitted by GE Healthcare Finland Oy (Helsinki, FI). The FDA issued a Cleared decision on October 4, 2010, 90 days after receiving the submission on July 6, 2010. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 870.2700.
Device Classification
| Product Code | DQA — Oximeter |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.2700 |
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