FDA 510(k) Applications for Medical Device:
Device, Sleep Assessment

FDA 510(k) Number Applicant Address City / Country State / Province Postal Code
K181077 ActiGraph 49 E Chase St
Pensacola FL 32502
K231532 ActiGraph, LLC 70 North Baylen Street, Suite 400
Pensacola FL 32504
K233987 Arbor Medical Innovations, LLC 168 S. Industrial Drive
Saline MI 48176
K981969 BRAEBON MEDICAL CORP. 63 ACKLAM TERRACE
KANATA K2K 2H7
K040986 CADWELL LABORATORIES, INC. 909 NORTH KELLOGG ST.
KENNEWICK WA 99336
K040932 CADWELL LABORATORIES, INC. 909 NORTH KELLOGG ST.
KENNEWICK WA 99336
K132764 CAMNTECH, LTD UPPER PENDRILL COURT
PAPWORTH EVERARD, CAMBRIDGESHIRE CB233UY
K151784 CONDOR INSTRUMENTS LTDA. - EPP AVENIDA BRIGADEIRO LUIS ANTONIO, 551, CJ 124
SAO PAULO 01318-000
K961817 KOVEN TECHNOLOGY, INC. 300 BROOKES DR.
ST. LOUIS MO 63042
K965079 NEURIM PHARMACEUTICALS, LTD. 12300 TWINBROOK PARKWAY, SUIT5
ROCKVILLE MD 20852
K233618 Oxehealth Limited Magdalen Centre North
Oxford OX4 4GA
K243513 PneumoWave, Ltd Suites 3 and 4, Second Floor, Maxim 3
Eurocentral ML1 4WQ
K003499 RESPIRONICS, INC. 1001 MURRY RIDGE LN.
MURRYSVILLE PA 15668
K111514 SLEEP PERFORMANCE D.B.A. FATIGUE SCIENCE 5405 ALTON PARKWAY
IRVINE CA 92604




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