DCTclock
DCTclock Practice Test Form - Research
2manufacturers in China registered for this device type
11catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (1), Guangdong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Bestcovered Limited | Shanghai | Shanghai | Manufacturer | 2 |
| Yiwei Medical Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 1 |
Record
| Listed by | Linus Health, Inc., United States |
|---|---|
| FDA product code | PTY |
| Device type | Computerized Cognitive Assessment Aid, Exempt |
| Device class | Class 2 |
| Regulation | 21 CFR 882.1470 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-02-16 |
| Record revised | 2020-08-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date, serial number |
| Packaging | Shrink wrap of 25, box of 2, shrink wrap of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 10003 | In distribution | |
| 10004 | In distribution | |
| 10039 | In distribution | |
| 10015 | In distribution | |
| 10093 | In distribution | |
| 10041 | In distribution | |
| 10005 | In distribution | |
| 10072 | In distribution | |
| 1110 | In distribution | |
| 10006 | In distribution | |
| 10096 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Intellispace™ Cognition | Philips Electronics Nederland B.V. | 6 |
| NeuroCatch Platform | NeuroCatch Inc. | 4 |
| Cognigram | Cogstate Ltd | 4 |
| NeuroCatch EEG Cap | NeuroCatch Inc. | 4 |
| Core Cognitive Evaluation | Linus Health, Inc. | 2 |
| Floodlight MS Cognitive Test | Roche Molecular Systems, Inc. | 2 |
| VRCogni | XR Health IL Ltd | 2 |
| Cognivue Clarity | Cognivue, Inc. | 2 |
| Cognivue Thrive | Cognivue, Inc. | 2 |
| Speech Vitals – Cognition | Aural Analytics, Inc. | 2 |
| Mspt Web v3.0 | Qr8 Health Inc | 1 |
| Happyneuron Cognitive Training | Happyneuron | 1 |
Showing 12 of 48. All products under Computerized Cognitive Assessment Aid, Exempt
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.