MASIMO CORPORATION

Entity profile compiled from public source records

Public Record Profile Registrations: 8 510(k) filings: 1 Recalls: 0

Known Identifiers & Locations

FEI Numbers 3004415095, 3005135175, 3009831876, 3011353843, 3013250653, 3016674095, 3019388613, 3027256461
Owner Operator Numbers 9031881, 9075000
Locations Covered Irvine, CA, US; Mexicali Baja California, MX; Mexicali Mexico, MX; Pasir Gudang Johor, MY; Tyreso, SE

Registered Establishments (8)

Registration # Establishment Name Location Establishment Type(s) Action
3004415095 Industrial Vallera de Mexicali, S. A. de C. V. Mexicali Mexico, MX Manufacture Medical Device View Details
3005135175 Frohe Sweden AB Tyreso, SE Manufacture Medical Device for Another Party (Contract Manufacturer) View Details
3009831876 MASIMO CORPORATION Irvine, CA, US Repack or Relabel Medical Device View Details
3011353843 MASIMO CORPORATION Irvine, CA, US Develop Specifications But Do Not Manufacture At This Facility View Details
3013250653 MASIMO CORPORATION Irvine, CA, US Manufacture Medical Device View Details
3016674095 Industrial Vallera de Mexicali, S.A. de C.V. (Terra) Mexicali Baja California, MX Manufacture Medical Device View Details
3019388613 Masimo Corporation Irvine, CA, US Complaint File Establishment per 21 CFR 820.198 View Details
3027256461 Masimo Medical Technologies (Malaysia) SDN BHD Pasir Gudang Johor, MY Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device View Details

510(k) Premarket Notifications (1)

Submission # Device Name Decision Date Decision Description Action
K201432 Masimo O3 Regional Oximeter System 2020-08-29 Substantially Equivalent View Details

FDA Recall History (0)

No recall records found for this entity.

Profile Disclaimer

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