Calgary Scientific Inc

FDA Filings

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

Calgary Scientific Inc holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

FDA Registration(s)
Registration Number3006123366
FEI Number3006123366
NameRene Van De Zande
Owner & OperatorCALGARY SCIENTIFIC, INC.
Contact AddressSUITE 200, 119 6 Ave SW --
CALGARY CA-AB Alberta T2P 0P8 CA
US Agent
Importing Logistics Registration
ImporterCalgary Scientific Inc.
Address3205 102 Avenue NE
Bellevue, WA 98004 UNITED STATES
Importer TypeAgent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address2500 Bee Cave Road Bldg 1, Suite 300
Austin, TX 78746 US
Establishment TypeManufacture Medical Device



FDA Filings

Device
Company
DeviceDate
Calgary Scientific Inc
ResolutionMD® Web 2018-09-24
Calgary Scientific Inc
ResolutionMD® Mobile 2018-09-24
Calgary Scientific Inc
ResolutionMD® 2018-09-24
Rene Van De Zande [CALGARY SCIENTIFIC, INC.]
ResolutionMD2016-12-09
CALGARY SCIENTIFIC, INC.
ResolutionMD2016-08-24
Rene Van De Zande [CALGARY SCIENTIFIC, INC.]
ResolutionMD Mobile2014-12-22
CALGARY SCIENTIFIC, INC.
RESOLUTIONMD MOBILE2014-03-26
Rene Van De Zande [CALGARY SCIENTIFIC, INC.]
ResolutionMD Mobile2013-12-23
CALGARY SCIENTIFIC, INC.
RESOLUTIONMD MOBILE 3.1 MODEL RMD-MOB-312013-03-14
Rene Van De Zande [CALGARY SCIENTIFIC, INC.]
ResolutionMD Web2013-01-17
CALGARY SCIENTIFIC, INC.
RESOLUTIONMD WEB2012-04-19
Rene Van De Zande [CALGARY SCIENTIFIC, INC.]
ResolutionMD Mobile2011-11-29
CALGARY SCIENTIFIC, INC.
RESOLUTIONMD MOBILE MODEL RMB-MOB-2X2011-09-09
Rene Van De Zande [CALGARY SCIENTIFIC, INC.]
ResolutionMD 2.12010-12-10
CALGARY SCIENTIFIC, INC.
RESOLUTIONMD, RELEASE 2.12009-02-23
Rene Van De Zande [CALGARY SCIENTIFIC, INC.]
ResolutionMD Cardiac Product Family2007-11-21
CALGARY SCIENTIFIC, INC.
RESOLUTIONMD CARDIAC PRODUCT FAMILY, MODEL: RELEASE 1.02007-06-01
Rene Van De Zande [CALGARY SCIENTIFIC, INC.]
RESOLUTIONMD2006-10-24
CALGARY SCIENTIFIC, INC.
RESOLUTIONMD, VERSION 1.32006-09-22

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