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Introduction

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510(k) Number (if known) K190713 Device Name F&P Vitera Full Face Mask Indications for Use (Describe) A Model The F&P Vitera Full Face mask is intended to be used by adults weighing ≥ 66lbs (30kgs) who have been diagnosed by a physician as requiring CPAP or Bi-Level therapy. The F&P Vitera Full Face mask is intended for single patient use in ...

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