Product code LEL
- Device name
- Device, Sleep Assessment
- Medical specialty
- Neurology
- Device class
- 2
- Regulation number
- 882.5050
- Review panel
- NE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252981 | EmbraceMini | Empatica S.r.l. | 2025-12-22 |
| K251574 | Sleep Watch | Ambulatory Monitoring, Inc. | 2025-07-31 |
| K243513 | DCM (PW-DCM) | Pneumowave, Ltd. | 2025-04-16 |
| K233987 | VERABAND™ | Arbor Medical Innovations, LLC | 2024-06-17 |
| K233618 | Oxevision Sleep Device | Oxehealth Limited | 2024-04-03 |
| K231532 | ActiGraph LEAP activity monitor (ActiGraph LEAP) | Actigraph, LLC | 2023-06-23 |
| K181077 | ActiGraph CentrePoint Insight Watch | Actigraph | 2018-05-24 |
| K151784 | ActTrust | Condor Instruments Ltda. - Epp | 2016-05-25 |
| K132764 | MOTION WATCH AND PRO-DIARY | Camntech, Ltd. | 2014-01-21 |
| K111514 | SBV2, MULTICHARGER MODEL MC10V2 | Sleep Performance D.B.A. Fatigue Science | 2011-12-16 |
| K040932 | EASYNET BODY POSITION MODULE | Cadwell Laboratories, Inc. | 2004-07-01 |
| K040986 | CADWELL LIMB MOVEMENT MODULE | Cadwell Laboratories, Inc. | 2004-07-01 |
| K003499 | REMVIEW SLEEP RECORDER, MODEL 320 | Respironics, Inc. | 2001-02-09 |
| K981969 | ULTIMA BODY POSITION SENSOR | Braebon Medical Corp. | 1998-08-20 |
| K961817 | B SMART MODEL 1 | Koven Technology, Inc. | 1997-07-23 |
| K965079 | SOMNITOR 32K SLEEP ACTIVITY MONITOR | Neurim Pharmaceuticals, Ltd. | 1997-07-10 |
| K912817 | SOMNIMIC (R) | Somnitec, Inc. | 1991-07-26 |
| K862766 | EPISON, ALERTING SYSTEM FOR EPILEPTICS | Zygo Industries, Inc. | 1987-03-13 |
| K792305 | A SLEEP ASSESSMENT DEVICE | Farrall Instruments, Inc. | 1979-12-20 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| G012BRCA05 | BioStamp® | Medidata Solutions, Inc. | 2021-04-01 |
| G012SW0028 | BioStamp nPoint™ | Medidata Solutions, Inc. | 2021-04-01 |
| G012SW0027 | BioStamp nPoint™ | Medidata Solutions, Inc. | 2021-04-01 |
| G012SW0026 | BioStamp nPoint™ | Medidata Solutions, Inc. | 2021-04-01 |
| G012SW0025 | BioStamp nPoint™ | Medidata Solutions, Inc. | 2021-04-01 |
| G012MC0015 | BioStamp nPoint™ | Medidata Solutions, Inc. | 2021-04-01 |
| G012MC0014 | BioStamp nPoint™ | Medidata Solutions, Inc. | 2021-04-01 |
| G012MC0013 | BioStamp nPoint™ | Medidata Solutions, Inc. | 2021-04-01 |
| G012MC0012 | BioStamp nPoint™ | Medidata Solutions, Inc. | 2021-04-01 |
| G012MC0008 | BioStamp nPoint™ | Medidata Solutions, Inc. | 2021-04-01 |
| G012MC0007 | BioStamp nPoint™ | Medidata Solutions, Inc. | 2021-04-01 |
| G012MC0006 | BioStamp nPoint™ | Medidata Solutions, Inc. | 2021-04-01 |
| G012MC0004 | BioStamp nPoint™ | Medidata Solutions, Inc. | 2021-04-01 |
| G012BRCA02 | BioStamp® nPoint | Medidata Solutions, Inc. | 2021-04-01 |
| G012BRCD02 | BioStamp® | Medidata Solutions, Inc. | 2021-04-01 |
| G012BRCP01 | BioStamp nPoint™ | Medidata Solutions, Inc. | 2021-04-01 |
| G012BRCP02 | BioStamp® nPoint | Medidata Solutions, Inc. | 2021-04-01 |
| G012BRCP03 | BioStamp® | Medidata Solutions, Inc. | 2021-04-01 |
| G012BRCS02 | BioStamp® | Medidata Solutions, Inc. | 2021-04-01 |
| G012BRCT01 | BioStamp nPoint™ | Medidata Solutions, Inc. | 2021-04-01 |
| G012BSPS01 | BioStamp® | Medidata Solutions, Inc. | 2021-04-01 |
| G012MC0003 | BioStamp nPoint™ | Medidata Solutions, Inc. | 2021-04-01 |
| G012MC0005 | BioStamp nPoint™ | Medidata Solutions, Inc. | 2021-04-01 |
| G012MC00022 | BioStamp® nPoint | Medidata Solutions, Inc. | 2021-03-01 |
| B493BRCA02 | BioStamp® | MC10, INC. | 2018-08-31 |
| B493BRCA05 | BioStamp® | MC10, INC. | 2018-08-31 |
| B493BRCD01 | BioStamp nPoint™ | MC10, INC. | 2018-08-31 |
| B493BRCD02 | BioStamp® | MC10, INC. | 2018-08-31 |
| B493BRCP01 | BioStamp nPoint™ | MC10, INC. | 2018-08-31 |
| B493BRCP02 | BioStamp nPoint™ | MC10, INC. | 2018-08-31 |