Envisen Inc

FDA Filings

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

FDA Registration(s)
Registration Number3007773209
FEI Number3007773209
NameSTEPHEN H. GORSKI
Owner & OperatorENVISEN INC.
Contact AddressBLOCK A SIMPLE DRAGON INDUSTRIAL PARK
SHENZHEN CN-NOTA 518000 CN
US Agent
Importing Logistics Registration
ImporterHealthcare Logistics Systems LLC
Address4348 NVV 120th Avenue Coral Springs Florida 33065
Coral Springs, FL 33065 UNITED STATES
Importing Logistics Registration
ImporterMAXTEC
Address2305 SOUTH 1070 WEST SALT LAKE CITY, UT 84119
Granger, UT 84119 UNITED STATES
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressS65 W35739 PIPER ROAD
Eagle, WI 53119 US
Establishment TypeManufacture Medical Device

FDA Filings

Device
Company
DeviceDate
STEPHEN H. GORSKI [ENVISEN INC.]
QView2018-07-05
STEPHEN H. GORSKI [ENVISEN INC.]
Qtube2018-04-17
STEPHEN H. GORSKI [ENVISEN INC.]
ExtendaFlow2018-04-17
STEPHEN H. GORSKI [ENVISEN INC.]
CoreFlow2018-04-17
STEPHEN H. GORSKI [ENVISEN INC.]
Envisen Reusable SPO2 Sensors2011-12-28
STEPHEN H. GORSKI [ENVISEN INC.]
Envisen Disposable and Reusable SPO2 Sensors2011-12-28
STEPHEN H. GORSKI [ENVISEN INC.]
Envisen Disposable SPO2 Sensors2011-12-28

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