K-number	K182189
Device name	Encompass SRS Headframe ; Encompass MR SRS Headframe
Applicant	Qfix
Product code	IYE
Device class	Class II
Decision date	Oct 4, 2018
Decision	Substantially Equivalent
Regulation	892.5050

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Source

View the full FDA submission: accessdata.fda.gov

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Encompass SRS Headframe ; Encompass MR SRS Headframe

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