Device, Sleep Assessment
FDA product code LEL · 18 cleared devices
Class 2
Neurology
- Regulation
- 21 CFR 882.5050
- Review panel
- NE
- Implant
- No
- Life sustaining
- No
- Third party review
- No
- GMP exempt
- No
- Clearance span
- 1979-12-20 – 2025-12-22
LEL
2025-12-22
LEL
2025-07-31
Sleep Watch
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LEL
2025-04-16
DCM (PW-DCM)
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LEL
2024-06-17
VERABAND™
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LEL
2024-04-03
Oxevision Sleep Device
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LEL
2023-06-23
ActiGraph LEAP activity monitor (ActiGraph LEAP)
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LEL
2018-05-24
ActiGraph CentrePoint Insight Watch
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LEL
2016-05-25
ActTrust
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LEL
2011-12-16
SBV2, MULTICHARGER MODEL MC10V2
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LEL
2004-07-01
CADWELL LIMB MOVEMENT MODULE
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LEL
2004-07-01
EASYNET BODY POSITION MODULE
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LEL
2001-02-09
REMVIEW SLEEP RECORDER, MODEL 320
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LEL
1998-08-20
ULTIMA BODY POSITION SENSOR
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LEL
1997-07-23
B SMART MODEL 1
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LEL
1997-07-10
SOMNITOR 32K SLEEP ACTIVITY MONITOR
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LEL
1991-07-26
SOMNIMIC (R)
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LEL
1987-03-13
EPISON, ALERTING SYSTEM FOR EPILEPTICS
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LEL
1979-12-20
A SLEEP ASSESSMENT DEVICE
View details →No matching devices.
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