510(k) K231532
K231532 is an FDA 510(k) premarket notification submitted by Actigraph, LLC for the device "ActiGraph LEAP activity monitor (ActiGraph LEAP)". The FDA issued a decision of Substantially Equivalent on June 23, 2023. The device falls under product code LEL (Device, Sleep Assessment), a Class II device regulated under 21 CFR 882.5050. Actigraph, LLC has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 23, 2023
- Date Received
- May 26, 2023
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device, Sleep Assessment
- Device Class
- Class II
- Regulation Number
- 882.5050
- Review Panel
- NE
- Submission Type