Name: Predicase
Price: 199 USD

K-number	K143395
Device name	Otoport OAE +ABR Advance, Otoport OAE+ABR DP+TE, Otoport OAE+ABR Screener-Otocheck OAE+ABR, Otocheck OAE+ABR LE, Otocheck ABR Screener-Otodynamics ABR Upgrade Kit
Applicant	Otodynamics, Ltd.
Product code	EWO
Device class	Class II
Decision date	Feb 23, 2015
Decision	Substantially Equivalent
Regulation	874.1050

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Source

View the full FDA submission: accessdata.fda.gov

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Otoport OAE +ABR Advance, Otoport OAE+ABR DP+TE, Otoport OAE+ABR Screener-Otocheck OAE+ABR, Otocheck OAE+ABR LE, Otocheck ABR Screener-Otodynamics ABR Upgrade Kit

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