FDA Product Code
FDA Product Code LEL — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Neurology
- 21 CFR Citation
- 882.5050
510(k) Clearances — 19 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K252981 | EmbraceMini | Empatica S.r.l. | 2025-12-22 | Traditional | PDF ↗ |
| K251574 | Sleep Watch | Ambulatory Monitoring, Inc. | 2025-07-31 | Special | PDF ↗ |
| K243513 | DCM (PW-DCM) | Pneumowave, Ltd. | 2025-04-16 | Traditional | PDF ↗ |
| K233987 | VERABAND | Arbor Medical Innovations, LLC | 2024-06-17 | Traditional | PDF ↗ |
| K233618 | Oxevision Sleep Device | Oxehealth Limited | 2024-04-03 | Traditional | PDF ↗ |
| K231532 | ActiGraph LEAP activity monitor (ActiGraph LEAP) | Actigraph, LLC | 2023-06-23 | Special | PDF ↗ |
| K181077 | ActiGraph CentrePoint Insight Watch | Actigraph | 2018-05-24 | Special | PDF ↗ |
| K151784 | ActTrust | Condor Instruments Ltda. - Epp | 2016-05-25 | Traditional | PDF ↗ |
| K132764 | MOTION WATCH AND PRO-DIARY | Camntech, Ltd. | 2014-01-21 | Traditional | PDF ↗ |
| K111514 | SBV2, MULTICHARGER MODEL MC10V2 | Sleep Performance D.B.A. Fatigue Science | 2011-12-16 | Traditional | PDF ↗ |
| K040986 | CADWELL LIMB MOVEMENT MODULE | Cadwell Laboratories, Inc. | 2004-07-01 | Traditional | PDF ↗ |
| K040932 | EASYNET BODY POSITION MODULE | Cadwell Laboratories, Inc. | 2004-07-01 | Traditional | PDF ↗ |
| K003499 | REMVIEW SLEEP RECORDER, MODEL 320 | Respironics, Inc. | 2001-02-09 | Abbreviated | PDF ↗ |
| K981969 | ULTIMA BODY POSITION SENSOR | Braebon Medical Corp. | 1998-08-20 | Traditional | PDF ↗ |
| K961817 | B SMART MODEL 1 | Koven Technology, Inc. | 1997-07-23 | Traditional | PDF ↗ |
| K965079 | SOMNITOR 32K SLEEP ACTIVITY MONITOR | Neurim Pharmaceuticals, Ltd. | 1997-07-10 | Traditional | PDF ↗ |
| K912817 | SOMNIMIC (R) | Somnitec, Inc. | 1991-07-26 | Traditional | PDF ↗ |
| K862766 | EPISON, ALERTING SYSTEM FOR EPILEPTICS | Zygo Industries, Inc. | 1987-03-13 | Traditional | PDF ↗ |
| K792305 | A SLEEP ASSESSMENT DEVICE | Farrall Instruments, Inc. | 1979-12-20 | Traditional | PDF ↗ |
Product code LEL · Class II · Neurology. Data: openFDA.