Primary Device ID | B626100060 |
NIH Device Record Key | 3b6c693f-320c-41c4-912d-ff155b07d287 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | DCTclock |
Version Model Number | 10006 |
Catalog Number | 10006 |
Company DUNS | 047303734 |
Company Name | DIGITAL COGNITION TECHNOLOGIES, INC. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | true |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | false |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | true |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
HIBCC | B626100060 [Primary] |
PTY | Computerized Cognitive Assessment Aid, Exempt |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2018-03-29 |
Device Publish Date | 2018-02-16 |
B62611100 | DCTclock System |
B626100960 | DCTclock System - Research |
B626100931 | DCTclock Practice Test Form - clinical |
B626100722 | DCTclock Test Form - Clinical |
B626100410 | DCTclock Uploader Software |
B626100391 | DCTclock Practice Test Form - Research |
B626100150 | DCTclock Cloud Platform |
B626100060 | DCTclock Micro USB Cable |
B626100050 | DCTclock Dock |
B626100040 | DCTclock Digital Pen |
B626100030 | DCTclock Test Form - Research |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
DCTCLOCK 97316012 not registered Live/Pending |
Linus Health, Inc. 2022-03-16 |