Ahead 300

GUDID 00852745007024

BRAINSCOPE COMPANY, INC.

Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph
Primary Device ID00852745007024
NIH Device Record Keye8e545c4-a0ae-4c8e-9a80-0630ab945f6d
Commercial Distribution StatusIn Commercial Distribution
Brand NameAhead 300
Version Model Number99-1403-002
Company DUNS805670416
Company NameBRAINSCOPE COMPANY, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone240-752-7680
Emailsabyasachi.roy@brainscope.com
Phone240-752-7680
Emailsabyasachi.roy@brainscope.com
Phone240-752-7680
Emailsabyasachi.roy@brainscope.com
Phone240-752-7680
Emailsabyasachi.roy@brainscope.com
Phone240-752-7680
Emailsabyasachi.roy@brainscope.com
Phone240-752-7680
Emailsabyasachi.roy@brainscope.com
Phone240-752-7680
Emailsabyasachi.roy@brainscope.com
Phone240-752-7680
Emailsabyasachi.roy@brainscope.com
Phone240-752-7680
Emailsabyasachi.roy@brainscope.com
Phone240-752-7680
Emailsabyasachi.roy@brainscope.com
Phone240-752-7680
Emailsabyasachi.roy@brainscope.com
Phone240-752-7680
Emailsabyasachi.roy@brainscope.com
Phone240-752-7680
Emailsabyasachi.roy@brainscope.com
Phone240-752-7680
Emailsabyasachi.roy@brainscope.com
Phone240-752-7680
Emailsabyasachi.roy@brainscope.com
Phone240-752-7680
Emailsabyasachi.roy@brainscope.com
Phone240-752-7680
Emailsabyasachi.roy@brainscope.com
Phone240-752-7680
Emailsabyasachi.roy@brainscope.com
Phone240-752-7680
Emailsabyasachi.roy@brainscope.com
Phone240-752-7680
Emailsabyasachi.roy@brainscope.com
Phone240-752-7680
Emailsabyasachi.roy@brainscope.com
Phone240-752-7680
Emailsabyasachi.roy@brainscope.com
Phone240-752-7680
Emailsabyasachi.roy@brainscope.com
Phone240-752-7680
Emailsabyasachi.roy@brainscope.com
Phone240-752-7680
Emailsabyasachi.roy@brainscope.com
Phone240-752-7680
Emailsabyasachi.roy@brainscope.com
Phone240-752-7680
Emailsabyasachi.roy@brainscope.com
Phone240-752-7680
Emailsabyasachi.roy@brainscope.com
Phone240-752-7680
Emailsabyasachi.roy@brainscope.com
Phone240-752-7680
Emailsabyasachi.roy@brainscope.com
Phone240-752-7680
Emailsabyasachi.roy@brainscope.com
Phone240-752-7680
Emailsabyasachi.roy@brainscope.com
Phone240-752-7680
Emailsabyasachi.roy@brainscope.com
Phone240-752-7680
Emailsabyasachi.roy@brainscope.com
Phone240-752-7680
Emailsabyasachi.roy@brainscope.com
Phone240-752-7680
Emailsabyasachi.roy@brainscope.com
Phone240-752-7680
Emailsabyasachi.roy@brainscope.com
Phone240-752-7680
Emailsabyasachi.roy@brainscope.com
Phone240-752-7680
Emailsabyasachi.roy@brainscope.com
Phone240-752-7680
Emailsabyasachi.roy@brainscope.com
Phone240-752-7680
Emailsabyasachi.roy@brainscope.com
Phone240-752-7680
Emailsabyasachi.roy@brainscope.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100852745007024 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OLUNormalizing Quantitative Electroencephalograph Software

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-10-25
Device Publish Date2018-09-24

Devices Manufactured by BRAINSCOPE COMPANY, INC.

00852745007260 - Baseline Headset2021-11-23 A variant of the electrode headset that is to be used for Baseline sessions.
00852745007239 - BrainScope One2021-02-24 BrainScope Part Number 99-1801-100 (SKU: BSO-2001) Contains Device Identifier (DI) 00852745007222 - this is the DI for the Brain
00852745007109 - Ahead 300 International Charging Kit2020-02-06
00852745007130 - BrainScope One International Charging Kit2020-02-06
00852745007024 - Ahead 3002018-10-25
00852745007024 - Ahead 3002018-10-25
00852745007048 - Ahead Electrode Headset2018-10-25
00852745007079 - Electrode Headset2018-10-25
00852745007123 - BrainScope One2018-10-25

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.