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The Onera STS I is CE marked (MDD 93/42/eec)
510(k) FDA
Cleared
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FDA 510k cleared and CE-marked refers to the Onera Sleep Test System, which is a Class IIa medical device. Onera STS includes the Onera STS I System, which is CE marked in Europe, and the Onera STS System, which was cleared the the Food and Drug Administration for use in the United States.