FDA issued a Warning Letter to Masimo Corporation on 8/12/2014 as a result of this inspection.
483 Masimo Oct 2013

483 Masimo Oct 2013

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FDA investigators audited the Masimo - Irvine, CA, United States facility and issued 9 inspectional observations (via FDA 483) on 03 Oct 2013.

Product details

  • Category: Medical Devices & Rad Health
  • Number of Observations: 9
  • Inspection end: 03 Oct 2013
  • Location: Irvine, United States
  • FEI: 3001452206
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