Brainscope

FDA Filings

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

FDA Registration(s)

• Registration Number: 3008660657
• FEI Number: 3008660657
• Name: BRAINSCOPE
• Owner & Operator: BrainScope Company, Inc.
• Contact Address: 4330 East West Highway, Suite 1000 ; Bethesda MD 20814 US
• Official Correspondent:
  • Betzaida Arguello
  • x-240-7527680-1066
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 4330 E WEST HWY STE 1000 ; Bethesda, MD 20814 US
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
PMN K190815 | PKQ BRAINSCOPE [BrainScope Company, Inc.]	BrainScope One (Model: Ahead 500)	2019-12-17
PMN K190815 | PIW BRAINSCOPE [BrainScope Company, Inc.]	BrainScope One (Model: Ahead 500)	2019-12-17
PMN K190815 | OLU BRAINSCOPE [BrainScope Company, Inc.]	BrainScope One (Model: Ahead 500)	2019-12-17
PMN K181179 | PKQ BRAINSCOPE [BrainScope Company, Inc.]	BrainScope One	2018-12-11
PMN K181179 | PIW BRAINSCOPE [BrainScope Company, Inc.]	BrainScope One	2018-12-11
PMN K181179 | OLU BRAINSCOPE [BrainScope Company, Inc.]	BrainScope One	2018-12-11
PMN K161068 | PKQ BRAINSCOPE [BrainScope Company, Inc.]	BrainScope One	2017-02-15
PMN K161068 | PKQ BRAINSCOPE [BrainScope Company, Inc.]	Ahead? 300	2017-02-15
PMN K161068 | PIW BRAINSCOPE [BrainScope Company, Inc.]	BrainScope One	2017-02-15
PMN K161068 | PIW BRAINSCOPE [BrainScope Company, Inc.]	Ahead? 300	2017-02-15
PMN K161068 | OLU BRAINSCOPE [BrainScope Company, Inc.]	BrainScope One	2017-02-15
PMN K161068 | OLU BRAINSCOPE [BrainScope Company, Inc.]	Ahead? 300	2017-02-15

Similar & Related FDA Registered Companies

• BrainScope Company, Inc.