Scotthoffman

FDA Filings

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

FDA Registration(s)
Registration Number3001708137
FEI Number3001708137
NameSCOTTHOFFMAN
Owner & OperatorHUMAN CARE CANADA INC.
Contact Address10-155 COLONDALE ROAD --
OTTAWA CA-NOTA K2E 7K1 CA
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address2775 BROADWAY
BUFFALO, NY 14227 US
Establishment Type
  • Export Device to the United States But Perform No Other Operation on Device
  • Foreign Private Label Distributor

Registration Number3003832357
FEI Number3003832357
NameSCOTTHOFFMAN
Owner & OperatorREMOTE DIAGNOSTIC TECHNOLOGIES LTD.
Contact AddressPavilion C2, Ashwood Park, Ashwood Way
Basingstoke GB-HAM Hampshire RG23 8BG GB
Official Correspondent
  • Martin - Newman
  • 44-125-634602-x
US Agent
Importing Logistics Registration
ImporterRemote Diagnostic Technologies Limited
AddressPavilion C2, Ashwood Park Ashwood Way
Basingstoke, RG23 8BG UNITED KINGDOM
SubdivisionGB-HAM
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address4902 N America Dr
West Seneca, NY 14224 US
Establishment Type
  • Manufacture Medical Device
  • Develop Specifications But Do Not Manufacture At This Facility
  • Complaint File Establishment per 21 CFR 820.198

FDA Filings

Device
Company
DeviceDate
SCOTTHOFFMAN [HUMAN CARE CANADA INC.]
PTS/acute care transfer kit H250/I-400/I-7002019-06-03
SCOTTHOFFMAN [HUMAN CARE CANADA INC.]
HUMAN CARE HC AB2017-05-10
SCOTTHOFFMAN [HUMAN CARE CANADA INC.]
HUMAN CARE HC AB - H250/I-400/I-7002017-05-10
SCOTTHOFFMAN [REMOTE DIAGNOSTIC TECHNOLOGIES LTD.]
Tempus IC22016-06-08
SCOTTHOFFMAN [HUMAN CARE CANADA INC.]
Human Care - FL 180; FL 320; Altair; Roomer S; HeliQ; STS 200; Roomer; Singel2016-02-17
SCOTTHOFFMAN [HUMAN CARE CANADA INC.]
Human Care - Floorline-i; Floorline-i Plus; Floorline LTC; P3; P5; LC600 Floorline2016-02-17
SCOTTHOFFMAN [REMOTE DIAGNOSTIC TECHNOLOGIES LTD.]
Tempus PRO Accessories (Ultrasound & Video Laryngoscope probe)2014-09-19
SCOTTHOFFMAN [REMOTE DIAGNOSTIC TECHNOLOGIES LTD.]
Tempus PRO Accessories (Ultrasound & Video Laryngoscope probe)2014-09-19
SCOTTHOFFMAN [REMOTE DIAGNOSTIC TECHNOLOGIES LTD.]
Tempus PRO Accessories (Ultrasound & Video Laryngoscope probe)2014-09-19
SCOTTHOFFMAN [REMOTE DIAGNOSTIC TECHNOLOGIES LTD.]
Tempus PRO extended features2014-09-19
SCOTTHOFFMAN [REMOTE DIAGNOSTIC TECHNOLOGIES LTD.]
Tempus PRO extended features2014-09-19
SCOTTHOFFMAN [REMOTE DIAGNOSTIC TECHNOLOGIES LTD.]
Tempus PRO extended features2014-09-19
SCOTTHOFFMAN [REMOTE DIAGNOSTIC TECHNOLOGIES LTD.]
Tempus PRO extended features2014-09-19
SCOTTHOFFMAN [REMOTE DIAGNOSTIC TECHNOLOGIES LTD.]
Tempus PRO extended features2014-09-19
SCOTTHOFFMAN [REMOTE DIAGNOSTIC TECHNOLOGIES LTD.]
Tempus PRO extended features2014-09-19
SCOTTHOFFMAN [REMOTE DIAGNOSTIC TECHNOLOGIES LTD.]
Tempus PRO With Enhanced Features2014-09-19
SCOTTHOFFMAN [REMOTE DIAGNOSTIC TECHNOLOGIES LTD.]
Tempus IC2014-06-02
SCOTTHOFFMAN [REMOTE DIAGNOSTIC TECHNOLOGIES LTD.]
Tempus Pro Patient Monitor Model numbers 00-1,00-1005,00-1006,00-10072013-06-11
SCOTTHOFFMAN [REMOTE DIAGNOSTIC TECHNOLOGIES LTD.]
Tempus IC Professional2010-05-13
SCOTTHOFFMAN [REMOTE DIAGNOSTIC TECHNOLOGIES LTD.]
Tempus IC2008-10-26
SCOTTHOFFMAN [REMOTE DIAGNOSTIC TECHNOLOGIES LTD.]
Consumables Replenishment kit2008-10-26
SCOTTHOFFMAN [HUMAN CARE CANADA INC.]
Human Care - Nexus 1; Nexus 2; Nexus 3; 4200 (LX,DX,SWX,WX); Carl-Oskar; Carla; Fellow; Parade; Rebel; Staffan2002-12-19

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