The following data is part of a premarket notification filed by Actigraph with the FDA for Actigraph Centrepoint Insight Watch.
| Device ID | K181077 |
| 510k Number | K181077 |
| Device Name: | ActiGraph CentrePoint Insight Watch |
| Classification | Device, Sleep Assessment |
| Applicant | ActiGraph 49 E Chase St Pensacola, FL 32502 |
| Contact | Brian Bell |
| Correspondent | Brian Bell ActiGraph 49 E Chase St Pensacola, FL 32502 |
| Product Code | LEL |
| CFR Regulation Number | 882.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-04-24 |
| Decision Date | 2018-05-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00853048008039 | K181077 | 000 |