FDA 510(k) Applications for Medical Device Product Code "LEL"
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FDA 510(k) Number | Applicant | Device Name | Decision Date |
K181077 | ActiGraph | ActiGraph CentrePoint Insight Watch | 05/24/2018 |
K231532 | ActiGraph, LLC | ActiGraph LEAP activity monitor (ActiGraph LEAP) | 06/23/2023 |
K981969 | BRAEBON MEDICAL CORP. | ULTIMA BODY POSITION SENSOR | 08/20/1998 |
K040986 | CADWELL LABORATORIES, INC. | CADWELL LIMB MOVEMENT MODULE | 07/01/2004 |
K040932 | CADWELL LABORATORIES, INC. | EASYNET BODY POSITION MODULE | 07/01/2004 |
K132764 | CAMNTECH, LTD | MOTION WATCH AND PRO-DIARY | 01/21/2014 |
K151784 | CONDOR INSTRUMENTS LTDA. - EPP | ActTrust | 05/25/2016 |
K961817 | KOVEN TECHNOLOGY, INC. | B SMART MODEL 1 | 07/23/1997 |
K965079 | NEURIM PHARMACEUTICALS, LTD. | SOMNITOR 32K SLEEP ACTIVITY MONITOR | 07/10/1997 |
K003499 | RESPIRONICS, INC. | REMVIEW SLEEP RECORDER, MODEL 320 | 02/09/2001 |
K111514 | SLEEP PERFORMANCE D.B.A. FATIGUE SCIENCE | SBV2, MULTICHARGER MODEL MC10V2 | 12/16/2011 |