Mexicali Terra Facility

FDA Filings

This page includes the latest FDA filings for Mexicali Terra Facility. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3016674095
FEI Number3016674095
NameMexicali (TERRA) Facility
Owner & OperatorMASIMO CORPORATION
Contact Address52 Discovery --
Irvine CA 92618 US
Official Correspondent
  • Mathew Jimenez
  • x-949-2977000-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressCarretera Mexicali-Algodones # 4798 Int. 4-1 Col. Diez Division Dos, Parque Industrial VIE VE
Mexicali Baja California, 21395 MX
Establishment Type
  • Manufacture Medical Device
  • Export Device to the United States But Perform No Other Operation on Device

FDA Filings

Device
Company
DeviceDate
Mexicali (TERRA) Facility [MASIMO CORPORATION]
Rad-97 Pulse CO-Oximeter2019-08-12
Mexicali (TERRA) Facility [MASIMO CORPORATION]
RD SET YI (Multisite) sensor2019-08-12
Mexicali (TERRA) Facility [MASIMO CORPORATION]
RD SET Trauma sensors2019-08-12
Mexicali (TERRA) Facility [MASIMO CORPORATION]
RD SET TC-I2019-08-12
Mexicali (TERRA) Facility [MASIMO CORPORATION]
RD SET Pdt disposable sensor2019-08-12
Mexicali (TERRA) Facility [MASIMO CORPORATION]
RD SET Newborn Neonatal sensor2019-08-12
Mexicali (TERRA) Facility [MASIMO CORPORATION]
RD SET Newborn Infant/Pediatric sensor2019-08-12
Mexicali (TERRA) Facility [MASIMO CORPORATION]
RD SET Neonatal disposable sensor2019-08-12
Mexicali (TERRA) Facility [MASIMO CORPORATION]
RD SET Infant disposable sensor2019-08-12
Mexicali (TERRA) Facility [MASIMO CORPORATION]
RD SET DCIP2019-08-12
Mexicali (TERRA) Facility [MASIMO CORPORATION]
RD SET DCI2019-08-12
Mexicali (TERRA) Facility [MASIMO CORPORATION]
RD SET Adt disposable sensor2019-08-12
Mexicali (TERRA) Facility [MASIMO CORPORATION]
Rad-67 Pulse CO-Oximeter2019-08-07
Mexicali (TERRA) Facility [MASIMO CORPORATION]
DCI Mini sensor2019-08-07
Mexicali (TERRA) Facility [MASIMO CORPORATION]
Radius-PPG2019-06-13
Mexicali (TERRA) Facility [MASIMO CORPORATION]
Masimo SafetyNet2019-06-13
Mexicali (TERRA) Facility [MASIMO CORPORATION]
Regional Oximetry System with O3 Neonatal Sensor2019-06-13

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