DCTclock 10072
GUDID B626100722
DCTclock Test Form - Clinical
DIGITAL COGNITION TECHNOLOGIES, INC.
Drawing-test cognitive function analysis device| Primary Device ID | B626100722 |
| NIH Device Record Key | a54506e6-1ed1-4c88-bf73-be94be52caa7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DCTclock |
| Version Model Number | 10072 |
| Catalog Number | 10072 |
| 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 | true |
| 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 |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B626100720 [Primary] |
| HIBCC | B626100721 [Package] Contains: B626100720 Package: shrink wrap [25 Units] In Commercial Distribution |
| HIBCC | B626100722 [Package] Contains: B626100721 Package: box [2 Units] In Commercial Distribution |
FDA Product Code
| PTY | Computerized Cognitive Assessment Aid, Exempt |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2018-02-16 |
On-Brand Devices [DCTclock]
| 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 |
Trademark Results [DCTclock]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 DCTCLOCK 97316012 not registered Live/Pending |
Linus Health, Inc. 2022-03-16 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.