Frohe Ab

FDA Filings

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

FDA Registration(s)

• Registration Number: 3005135175
• FEI Number: 3005135175
• Name: FROHE AB
• Owner & Operator: Masimo Sweden AB
• Contact Address: SVARDVAGEN 15 --; DANDERYD SE-NOTA SE-182 33 SE
• Official Correspondent:
  • Johan - Skold
  • 46-8544-98150-x
• US Agent:
  • Mathew Jimenez
  • Masimo Corporation
  • 949 2977558
  • mjimenez@masimo.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: STROMFALLSVAGEN 4 ; Tyreso Stockholms lan [SE-01], 13549 SE
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
PMN K123043 | NHQ FROHE AB [Masimo Sweden AB]	IRMA - Infrared Mainstream Gas Analyzer	2013-01-31
PMN K123043 | NHP FROHE AB [Masimo Sweden AB]	IRMA - Infrared Mainstream Gas Analyzer	2013-01-31
PMN K123043 | NHO FROHE AB [Masimo Sweden AB]	IRMA - Infrared Mainstream Gas Analyzer	2013-01-31
PMN K123043 | CCK FROHE AB [Masimo Sweden AB]	IRMA - Infrared Mainstream Gas Analyzer	2013-01-31
PMN K123043 | CBS FROHE AB [Masimo Sweden AB]	IRMA - Infrared Mainstream Gas Analyzer	2013-01-31
PMN K123043 | CBR FROHE AB [Masimo Sweden AB]	IRMA - Infrared Mainstream Gas Analyzer	2013-01-31
PMN K123043 | CBQ FROHE AB [Masimo Sweden AB]	IRMA - Infrared Mainstream Gas Analyzer	2013-01-31
PMN K103604 | CCK FROHE AB [Masimo Sweden AB]	ISA OR+	2011-08-25
PMN K103604 | CCK FROHE AB [Masimo Sweden AB]	ISA CO2	2011-08-25
PMN K103604 | CCK FROHE AB [Masimo Sweden AB]	ISA AX+	2011-08-25
PMN K072813 | CCK FROHE AB [Masimo Sweden AB]	EMMA Emergency Capnometer	2008-11-29
PMN K072813 | CCK FROHE AB [Masimo Sweden AB]	Capnocheck Capnometer	2008-11-29

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020010380435	Anvers,Belgium -> San Juan, Puerto Rico	RADISTOP SF	2 PKG
2020010380439	Anvers,Belgium -> San Juan, Puerto Rico	RADISTOP SF	2 PKG
2018122536056	Anvers,Belgium -> San Juan, Puerto Rico	PLASTIC PACKING MATERIALS	4 PKG
2018122536061	Anvers,Belgium -> San Juan, Puerto Rico	PLASTIC PACKING MATERIALS	2 PKG
2018102756956	Anvers,Belgium -> San Juan, Puerto Rico	PLASTIC PACKING MATERIALS	2 PKG
2018101652302	Anvers,Belgium -> San Juan, Puerto Rico	PLASTIC PACKING MATERIALS	2 PKG
2018080949260	Anvers,Belgium -> San Juan, Puerto Rico	PLASTIC PACKING MATERIALS	4 PKG
2018070760394	Anvers,Belgium -> New York/Newark Area, Newark, New Jersey	PLASTIC DETAILS	4 PKG