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FDA Warning Letter — Masimo Corporation

Case 420381 — FEI 3001452206

The FDA took a Warning Letter action against Masimo Corporation on August 13, 2014 (Irvine, CA). The action was issued by CDRH and concerns devices products. This facility has 5 or more recent FDA inspections on record.

Action Details

Facility
Masimo Corporation
Date
August 13, 2014
Fiscal Year
2014
Product Type
Devices
Center
CDRH
Location
Irvine, CA (United States)

Facility

Recent inspections

  • 1067514 (NAI Thu Sep 13 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1011370 (NAI Fri May 05 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 851391 (OAI Thu Oct 03 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 711962 (NAI Fri Feb 11 2011 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 649261 (NAI Wed Feb 03 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

FDA data resources